Data / Medical devices / United States / Laser Peripherals LLC.
Laser Peripherals LLC.: FDA-registered device maker in Plymouth, MN, United States, 8 510(k) clearances
Laser Peripherals LLC. is registered with the FDA (registration 1221543) in Plymouth, MN, United States. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated June 8, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221543
- Address
- 13355 10th ave SUITE 110, Plymouth, MN, United States, 55441
- Owner or operator
- LASER PERIPHERALS LLC. (1221543)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- Bare Laser Fiber, Bare Laser fibers, DBLF-60SF, DBLF-XX, Holmium Laser Fibers, LP Surgical Fibers, LS-905 Fiberchoice Adaptor system, Laser Peripherals LLC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, Manufacturer | 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 8, 2017 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| April 25, 2003 | K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| July 24, 2001 | K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| July 12, 1999 | K992083 | SCATTERFREE LATERAL EMITTING FIBER | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| February 10, 1998 | K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| July 29, 1997 | K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| June 27, 1996 | K961516 | LASER PERIPHERALS INC. BARE FIBER | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
| May 22, 1996 | K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | GEX | Substantially Equivalent | Laser Peripherals, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 20, 2014 | 68674 | Class II | Terminated | LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'. | accessdata.fda.gov |
Compare with other makers
Updated June 8, 2017. 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.