FIBERLASE ENDURE CO2 FIBER
FDA 510(k) clearance K130164 · decided 2013-03-24
Clearance details
- K-number
- K130164
- Device name
- FIBERLASE ENDURE CO2 FIBER
- Applicant
- Lumenis, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-23
- Decision date
- 2013-03-24
- Days to decision
- 60 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
- Binyamina, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including a recall (Z-2344-2025) | LUMENIS, LTD. | 2025-08-21 |