K242142
- 510(k) number
- K242142
- Device name
- Fraxel® FTX Laser System
- Applicant
- Solta Medical WA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-08-21
- Date received
- 2024-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242142
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.