DeviceClearance

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)— 510(k) K261221

Substantially Equivalent

Olympus Surgical Technologies America

FDA 510(k) clearance K261221 for SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), Substantially Equivalent on 2026-07-24. Applicant: Olympus Surgical Technologies America. Device class: 2.

Summary

Olympus Surgical Technologies America's SOLTIVE Laser System covers the SOLTIVE Pro and SOLTIVE Premium SuperPulsed Lasers, plus SOLTIVE laser fibers and accessories. It's filed under GEX, powered laser surgical instruments, and the record doesn't give wavelengths or power.

Class II, 21 CFR 878.4810. The Gastroenterology and Urology review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.

Olympus filed from Westborough, Massachusetts. Review took 101 calendar days (April 14 to July 24, 2026).

Clearance details

Applicant
Olympus Surgical Technologies America
Product code
Product code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westborough, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.