BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
FDA 510(k) clearance K030959 · decided 2003-04-25
Clearance details
- K-number
- K030959
- Device name
- BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
- Applicant
- Laser Peripherals, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-03-27
- Decision date
- 2003-04-25
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Golden Valley, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical ins recall (Z-2073-2014) | Laser Peripherals LLC | 2014-07-17 |