Thermage CPT System and Accessories
FDA 510(k) clearance K173759 · decided 2018-01-08
Clearance details
- K-number
- K173759
- Device name
- Thermage CPT System and Accessories
- Applicant
- Solta Medical
- Decision
- Substantially Equivalent
- Date received
- 2017-12-11
- Decision date
- 2018-01-08
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF T recall (Z-1354-2023) | Solta Medical Inc | 2023-04-07 |