Data / Medical devices / United States / Cynosure, LLC
Cynosure, LLC: FDA-registered device maker in Westford, MA, United States, 94 510(k) clearances
Cynosure, LLC is registered with the FDA (registration 1222993) in Westford, MA, United States. It lists 23 device types. The FDA files 94 510(k) clearances under its listings, the newest dated June 17, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1222993
- FEI number
- 1000120578
- Address
- 5 Carlisle RD, Westford, MA, United States, 01886
- Owner or operator
- CYNOSURE, LLC (9006419)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- ADIVIVE, AFFINITY QS, APEX ER. YAG / IPL SYSTEM, ARTISAN, ASPIRE, Acclaim Laser, Accolade Laser, Ace-Tip Electrodes, Bayonet Turbinate Electrode, Tonsillectomy Probe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | FYD | 2 | Complaint file establishment | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Electrosurgical | JOS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical Patient Return Electrode | ODR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Laser, Cellulite Appearance | OYW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Anesthesia, Paracervical | HEE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Complaint file establishment | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Unit, Electrosurgical, And Accessories, Dental | EKZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2026 | K261570 | PICOSURE WORKSTATION | GEX | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| March 8, 2024 | K240396 | Elite iQ PRO (M122K1) | GEX | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| January 2, 2024 | K233550 | MOSAIC 3D (Surgical Laser) | ONG | Substantially Equivalent | Lutronic Aesthetic | accessdata.fda.gov |
| November 23, 2022 | K223292 | TempSure System | GEI | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| March 18, 2022 | K212891 | TempSure System | GEI | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| February 4, 2022 | K213569 | HOLLYWOOD SPECTRA Laser System | GEX | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| March 30, 2021 | K210226 | PicoSure Workstation | GEX | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| March 26, 2021 | K203788 | DermaV Laser System | GEX | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| March 25, 2020 | K200241 | TempSure System | PBX | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| March 9, 2020 | K193426 | Elite iQ | GEX | Substantially Equivalent | Cynosure, LLC | accessdata.fda.gov |
| November 12, 2019 | K192331 | LaseMD LEO Laser System | GEX | Substantially Equivalent | Lutronic Global | accessdata.fda.gov |
| July 24, 2019 | K190678 | TempSure | GEI | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| June 14, 2019 | K183566 | CLARITY II Laser System | GEX | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| January 3, 2019 | K182741 | SculpSure | PKT | Substantially Equivalent | Cynosure | accessdata.fda.gov |
| December 10, 2018 | K180945 | LUTRONIC GENIUS Radiofrequency System | GEI | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| October 24, 2018 | K182365 | TempSure System | GEI | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| February 7, 2018 | K173199 | PicoSure Workstation | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 26, 2017 | K171992 | SculpSure | PKT | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 22, 2017 | K171262 | TempSure | GEI | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| June 13, 2017 | K171111 | Sculpsure | PKT | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| July 21, 2016 | K160470 | SculpSure | PKT | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| May 17, 2016 | K160480 | PicoSure Workstation | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| July 21, 2015 | K150587 | Cortex Laser System | GEX | Substantially Equivalent | Cynosure, Inc. Dba Ellman | accessdata.fda.gov |
| July 1, 2015 | K150724 | SculpSure | PKT | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| May 15, 2015 | K150230 | SculpSure | PKT | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| February 23, 2015 | K143105 | Picosure Workstation | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| January 23, 2015 | K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 24, 2014 | K142376 | Palomar Icon Aesthetic System | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 22, 2014 | K140719 | PICOSURE WORKSTATION | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 11, 2014 | K141425 | ELITE + LASER SYSTEM | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| July 22, 2014 | K133364 | PICOSURE WORKSTATION | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| February 20, 2014 | K132949 | PELLEFIRM | PBX | Substantially Equivalent | Ellman International, Inc. | accessdata.fda.gov |
| September 25, 2013 | K132665 | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC | GEI | Substantially Equivalent | Ellman International, Inc. | accessdata.fda.gov |
| July 12, 2013 | K123366 | SURGITRON 4.0 DUAL RF S5-IEC | GEI | Substantially Equivalent | Ellman International, Inc. | accessdata.fda.gov |
| March 29, 2013 | K123407 | CELLULAZE LASER | OYW | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| November 27, 2012 | K121346 | PICOSURE WORKSTATION | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| July 18, 2012 | K121162 | POLARIS Q-SWITCH RUBY SYSTEM | GEX | Substantially Equivalent | Sandstone Medical Technologies, LLC | accessdata.fda.gov |
| June 19, 2012 | K113668 | HEALITE II SYSTEM | ILY | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| May 23, 2012 | K120622 | PALOMAR VECTUS LASER | GEX | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| May 13, 2012 | K121127 | SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| January 26, 2012 | K102541 | CYNOSURE CELLULAZE LASER | OYW | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| November 14, 2011 | K111840 | EMERGE FRACTIONAL LASER | ONG | Substantially Equivalent | Palomar Medical Products, Inc. | accessdata.fda.gov |
| July 1, 2011 | K110897 | CORTEX CO2 / ER:YAG LASER SYSTEM | GEX | Substantially Equivalent | Sandstone Medical Technologies, LLC | accessdata.fda.gov |
| June 22, 2011 | K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | GEX | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| April 27, 2011 | K110502 | TRIPLEX ER. YAG / ND: YAG SYSTEM | GEX | Substantially Equivalent | Sandstone Medical Technologies, LLC | accessdata.fda.gov |
| April 8, 2011 | K110304 | APEX ER. YAG / IPL SYSTEM | GEX | Substantially Equivalent | Sandstone Medical Technologies, LLC | accessdata.fda.gov |
| January 20, 2011 | K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS | ONG | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| January 5, 2011 | K102698 | PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE | GEI | Substantially Equivalent | Ellman Int'L, Inc. | accessdata.fda.gov |
| November 19, 2010 | K103118 | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR | GEX | Substantially Equivalent | Hoya Photonics, Inc. | accessdata.fda.gov |
| September 23, 2010 | K101601 | AFFIRM DO DIODE LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 1, 2010 | K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | ONG | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| July 8, 2010 | K101415 | THERACLEAR | GEX | Substantially Equivalent | Theravant Corporation | accessdata.fda.gov |
| June 16, 2010 | K100893 | CHEVEUX DIODE LASER SYSTEM | GEX | Substantially Equivalent | Sandstone Medical Technologies, LLC | accessdata.fda.gov |
| April 2, 2010 | K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | NUV | Substantially Equivalent | Eleme Medical, Inc. | accessdata.fda.gov |
| March 29, 2010 | K100270 | ARTISAN AESTHETIC SYSTEM | GEX | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| November 20, 2009 | K090195 | PALOMAR LUX1540 HANDPIECE | GEX | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| September 3, 2009 | K091537 | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| May 18, 2009 | K083455 | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 | MUU | Substantially Equivalent | Medi-Khan USA, Inc. | accessdata.fda.gov |
| May 13, 2009 | K091169 | ELITE MPX LASER SYSTEM WITH CRYO C | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| April 14, 2009 | K090618 | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| March 19, 2009 | K081424 | AFFIRM CO2 AND AFFIRM CO2 HP | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| February 19, 2009 | K083629 | SMOOTHSHAPES | NUV | Substantially Equivalent | Eleme Medical, Inc. | accessdata.fda.gov |
| February 13, 2009 | K083165 | PALOMAR ASPIRE LASER PLATFORM | GEX | Substantially Equivalent | Palomar Medical Products, Inc. | accessdata.fda.gov |
| January 21, 2009 | K083795 | CYNOSURE SMARTLIPO MPX LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| May 5, 2008 | K081181 | SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| February 28, 2008 | K071343 | ELLMAN NOBLE ALLOY ELECTRODES | GEI | Substantially Equivalent | Ellman International, Inc. | accessdata.fda.gov |
| November 5, 2007 | K072868 | ACCOLADE II LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| January 30, 2007 | K070063 | YAG MIR II LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| December 6, 2006 | K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| December 1, 2006 | K063112 | REVLITE Q-SWITCHED ND:YAG LASER | GEX | Substantially Equivalent | Hoya Conbio, Inc. | accessdata.fda.gov |
| October 31, 2006 | K062321 | SMARTLIPO ND:YAG LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| February 13, 2006 | K053608 | CYNOSURE PHOTOGENICA V-STAR LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 14, 2005 | K050382 | AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| June 27, 2005 | K050779 | CYNERGY MULTIPLEX LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| June 17, 2005 | K050696 | MEDLITE C1 Q-SWITCHED ND:YAG LASER | GEX | Substantially Equivalent | Hoya Photonics, Inc. | accessdata.fda.gov |
| April 7, 2005 | K042710 | SURGITRON RADIOLASE II | GEI | Substantially Equivalent | Ellman Int'L, Inc. | accessdata.fda.gov |
| January 13, 2005 | K041086 | PALOMAR STARLUX PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | Palomar Medical Products, Inc. | accessdata.fda.gov |
| March 10, 2004 | K033549 | STARLUX PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | Palomar Medical Products, Inc. | accessdata.fda.gov |
| February 9, 2004 | K034030 | APOGEE ELITE | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| January 22, 2004 | K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | ISA | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| November 17, 2003 | K032539 | CYNOSURE PHOTOGENICA SV LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| July 8, 2003 | K031258 | CYNOSURE PHOTOLIGHT PL | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| June 4, 2003 | K031488 | CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020453 | PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER | GEX | Substantially Equivalent | Palomar Medical Technologies, Inc. | accessdata.fda.gov |
| January 17, 2002 | K014234 | MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER | GEX | Substantially Equivalent | Continuum Electro-Optics, Inc. | accessdata.fda.gov |
| November 7, 2001 | K013255 | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF | GEI | Substantially Equivalent | Ellman Intl., Inc. | accessdata.fda.gov |
| September 7, 2001 | K011828 | CYNOSURE ACCLAIM DERMATOLOGY LASER | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| March 13, 2000 | K000490 | CYNOSURE PHOTOGENICA VLS-STAR | GEX | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| August 11, 1999 | K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
| June 19, 1997 | K972072 | SURGITRON MODEL FFPF-EMC | GEI | Substantially Equivalent | Ellman Intl., Inc. | accessdata.fda.gov |
| May 12, 1997 | K963340 | MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE | GEX | Substantially Equivalent | Continuum Biomedical, Inc. | accessdata.fda.gov |
| April 15, 1996 | K955176 | DENTO-SURGE | EKZ | Substantially Equivalent | Ellman Intl., Inc. | accessdata.fda.gov |
| February 29, 1996 | K954718 | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE | HEE | Substantially Equivalent | Ellman Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2014 | 69463 | Class II | Terminated | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System | If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Updated June 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.