IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
FDA 510(k) clearance K232568 · decided 2024-03-21
Clearance details
- K-number
- K232568
- Device name
- IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
- Applicant
- Ipg Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-08-24
- Decision date
- 2024-03-21
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. recall (Z-2554-2026) | IPG Medical Corporation | 2026-06-24 |