Total clearances
2
2022-12-29 → 2024-08-21
Name variants in FDA filings: Solta Medical / Solta Medical, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| GEX |
Powered Laser Surgical Instrument |
Class II |
General, Plastic Surgery |
2 |
2024-08-21 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2023-02-16 |
Class II
|
Ongoing |
Z-1354-2023 |
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.… |
— |
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. |
Filings
All 510(k) clearances (2)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-08-21 |
K242142 |
Fraxel® FTX Laser System |
GEX |
Class II |
General, Plastic Surgery |
| 2022-12-29 |
K223647 |
CLEAR+BRILLIANT TOUCH® Laser System |
GEX |
Class II |
General, Plastic Surgery |