Data / Medical devices / United States / Iridex Corporation
Iridex Corporation: FDA-registered device maker in Mountain View, CA, United States, 36 510(k) clearances
Iridex Corporation is registered with the FDA (registration 2939653) in Mountain View, CA, United States. It lists 10 device types. The FDA files 36 510(k) clearances under its listings, the newest dated February 23, 2023. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2939653
- Address
- 1212 Terra Bella Avenue, Mountain View, CA, United States, 94043
- Owner or operator
- Iridex Corporation (9001789)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 3, 2008
- Registered through
- 2026
- Brand names listed
- 10 Pack Box, 23 Ga Cannula, Green Tip, Soft Tip 1 Mm, 10 Pack Box, 23 Ga Cannula, GreenTip, Soft Tip 0.5 mm, 10 Pack Box, 25 Ga Cannula, Green Tip, Soft Tip 1 Mm, 10 Pack Box, 25 Ga Cannula, GreenTip, Soft Tip 0.5 Mm, G-Probe Illuminate, Green Tip, GreenTipTM Soft Tip Cannula 20 Gauge Brush Tip Length: 2.5 MM Box (Qty 12), GreenTipTM Soft Tip Cannula 20 Gauge Tip Length: 0.5 MM Box (Qty 12) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Manufacturer | accessdata.fda.gov |
| Endoilluminator | MPA | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Projector, Ophthalmic | HOS | 1 | Manufacturer | accessdata.fda.gov |
| Table, Instrument, Powered, Ophthalmic | HRJ | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 23, 2023 | K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | HQF | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| November 9, 2022 | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | HQF | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| October 21, 2020 | K202760 | Iridex 810 Laser | HQF | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| September 5, 2018 | K181662 | Iridex TruFocus LIO Premiere | GEX | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| May 25, 2018 | K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | HQF | Substantially Equivalent | Topcon Medical Laser Systems, Inc. | accessdata.fda.gov |
| November 27, 2017 | K171488 | PSLT for PASCAL Streamline | HQF | Substantially Equivalent | Topcon Medical Laser Systems, Inc. | accessdata.fda.gov |
| September 12, 2017 | K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System | GEX | Substantially Equivalent | Topcon Medical Laser Systems, Inc. (Tmls) | accessdata.fda.gov |
| May 3, 2017 | K170718 | Iridex TruFocus LIO Premiere | GEX | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| September 29, 2016 | K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | GEX | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| January 2, 2015 | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | GEX | Substantially Equivalent | Iridex Corporation | accessdata.fda.gov |
| May 15, 2013 | K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | HQF | Substantially Equivalent | Topcon Medical Laser Systems, Inc. | accessdata.fda.gov |
| November 28, 2012 | K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| November 13, 2012 | K123056 | PASCAL LASER INDIRECT OPHTHALMOSCOPE | HQF | Substantially Equivalent | Topcon Medical Laser Systems, Inc. (Tmls) | accessdata.fda.gov |
| August 11, 2011 | K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | HQF | Substantially Equivalent | Topcon Medical Laser Systems, Inc. | accessdata.fda.gov |
| May 4, 2010 | K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| September 25, 2009 | K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | Substantially Equivalent | Topcon Medical Laser Systems, Inc. | accessdata.fda.gov |
| July 15, 2009 | K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | GEX | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| September 9, 2008 | K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | GEX | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| August 7, 2008 | K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| November 14, 2006 | K062074 | IRIDEX WIRELESS FOOTSWITCH | HQF | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| November 8, 2006 | K062369 | IRIDEX OCULIGHT TX | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| October 19, 2006 | K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | GEX | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| May 31, 2006 | K060905 | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| April 14, 2005 | K050562 | OCULIGHT GL/GLX | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| March 3, 2005 | K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | GEX | Substantially Equivalent | Topcon Medical Laser Systems, Inc. | accessdata.fda.gov |
| September 20, 2004 | K040209 | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR | HQF | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| August 27, 2003 | K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | HQF | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| October 8, 2002 | K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| May 20, 2002 | K020849 | APEX 800 LASER SYSTEM, MODEL APEX 800 | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| May 3, 2002 | K020374 | OCULIGHT SL/SLX | HQF | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| December 9, 1999 | K992298 | IRIDERM, MODEL APEX 800 | GEX | Substantially Equivalent | Iridex Corp | accessdata.fda.gov |
| November 9, 1999 | K992836 | SL990, SL980, SL950 | HJO | Substantially Equivalent | Cso | accessdata.fda.gov |
| February 19, 1998 | K974561 | MOISTAIR FLUID AIR TUBING SET | KYG | Substantially Equivalent | American Medical Devices, Inc. | accessdata.fda.gov |
| August 6, 1997 | K971853 | ENDOVIEW SPPHIRE LENS SET | HJK | Substantially Equivalent | American Medical Devices, Inc. | accessdata.fda.gov |
| May 20, 1997 | K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) | MPA | Substantially Equivalent | American Medical Devices, Inc. | accessdata.fda.gov |
| May 20, 1997 | K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | HMX | Substantially Equivalent | American Medical Devices, 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 |
|---|---|---|---|---|---|---|
| February 27, 2018 | 79386 | Class II | Terminated | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allow | It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns. | accessdata.fda.gov |
| July 15, 2016 | 74724 | Class II | Terminated | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode. | accessdata.fda.gov |
| March 27, 2012 | 65688 | Class II | Terminated | PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. | When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. | accessdata.fda.gov |
Compare with other makers
- All makers of Laser, Ophthalmic
- All makers of Powered Laser Surgical Instrument
- All makers of Endoilluminator
- All makers of Device, Irrigation, Ocular Surgery
- All makers of Cannula, Ophthalmic
- All makers of Table, Instrument, Powered, Ophthalmic
Updated February 23, 2023. 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.