510(k) clearance
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- 510(k) number
- K262877
- Applicant
- Olympus Surgical Technologies America
- Decision date
- Sep 16, 2026
- Date received
- Aug 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- GEX
- Device type
- Powered Laser Surgical Instrument
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Westborough, MA, US