Laser Peripherals LLC
Plymouth, MN, US
LASER PERIPHERALS LLC. appears in FDA device records in Plymouth, MN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Laser Peripherals LLC between 1988 and 2017. The busiest year on record is 1988, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 3 |
| 1990 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | GEX | Substantially Equivalent | |
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | GEX | Substantially Equivalent | |
| K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | GEX | Substantially Equivalent | |
| K992083 | SCATTERFREE LATERAL EMITTING FIBER | GEX | Substantially Equivalent | |
| K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | GEX | Substantially Equivalent | |
| K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | GEX | Substantially Equivalent | |
| K961516 | LASER PERIPHERALS INC. BARE FIBER | GEX | Substantially Equivalent | |
| K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | GEX | Substantially Equivalent | |
| K901786 | LASEGUIDE CAT # CLF-600D & CLF-1000D | GEX | Substantially Equivalent | |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | HHR | Substantially Equivalent | |
| K880592 | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | LLO | Substantially Equivalent | |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | FCS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221543 | 1221543 | LASER PERIPHERALS LLC. | 13355 10th ave, Plymouth, MN 55441 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2073-2014 | 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'. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain