K242191
- 510(k) number
- K242191
- Device name
- SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- Applicant
- Olympus Surgical Technologies America MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-08-23
- Date received
- 2024-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242191.pdf
Official FDA record: K242191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.