Laser Peripherals, LLC
Medical device manufacturer in Plymouth, MN.
12510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser FibersGEX · Traditional | 06/08/2017SE |
| K030959 | Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100GEX · Special | 04/25/2003SE |
| K011207 | Laser Peripherals Reusable Holmium FiberGEX · Traditional | 07/24/2001SE |
| K992083 | Scatterfree Lateral Emitting FiberGEX · Special | 07/12/1999SE |
| K974229 | LS-905 Fiberchoice Adapter SystemGEX · Traditional | 02/10/1998SE |
| K972272 | Laser Peripherals Holmium Bare FibersGEX · Traditional | 07/29/1997SE |
| K961516 | Laser Peripherals Inc. Bare FiberGEX · Traditional | 06/27/1996SE |
| K961079 | Laser Peripherals Inc. Scatterfree FiberGEX · Traditional | 05/22/1996SE |
| K901786 | Laseguide Cat # CLF-600D & CLF-1000DGEX · Traditional | 06/27/1990SE |
| K880591 | Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional | 06/01/1988SE |
| K880592 | Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional | 04/25/1988SE |
| K874680 | Laseguide 600A, 600B, 400A, and 400BFCS · Traditional | 03/23/1988SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2073-2014 Class II | LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical…Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility… | 06/20/2014Terminated |