K261221
- 510(k) number
- K261221
- 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
- 2026-07-24
- Date received
- 2026-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261221.pdf
Official FDA record: K261221
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.