Solea
FDA 510(k) clearance K221761 · decided 2022-09-14
Clearance details
- K-number
- K221761
- Device name
- Solea
- Applicant
- Convergent Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-17
- Decision date
- 2022-09-14
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NVK
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foo recall (Z-0324-2024) | Convergent Dental | 2023-11-17 |