Laser Peripherals LLC
FDA Regulatory Profile
Laser Peripherals LLC appears in FDA public data with 1 recall, 12 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2073-2014, Class II) was initiated on June 20, 2014. Its most recent 510(k) clearance was granted on June 8, 2017.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2073-2014 | Class II | LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrumen | June 20, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | June 8, 2017 |
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | April 25, 2003 |
| K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | July 24, 2001 |
| K992083 | SCATTERFREE LATERAL EMITTING FIBER | July 12, 1999 |
| K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | February 10, 1998 |
| K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | July 29, 1997 |
| K961516 | LASER PERIPHERALS INC. BARE FIBER | June 27, 1996 |
| K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | May 22, 1996 |
| K901786 | LASEGUIDE CAT # CLF-600D & CLF-1000D | June 27, 1990 |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | June 1, 1988 |
| K880592 | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | April 25, 1988 |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | March 23, 1988 |