510(k) K242191 · GEX Powered Laser Surgical Instrument
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
| Applicant | Olympus Surgical Technologies America, Westborough MA, US |
| Decision | Substantially Equivalent, Aug 23, 2024 |
| Received | Jul 25, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2026 | Olympus Corporation of the Americas Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System
Product Name: SOLTIVE Premium Laser System TFL-PLS
Model/Catalog Number: TFL-PLS containing TFL-CPLU
Product Description: An electricity po Open, Classified |
GEX | None listed |
| Mar 30, 2026 | Olympus Corporation of the Americas Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System
Product Name: SOLTIVE Pro Laser System TFL-SLS
Model/Catalog Number: TFL-SLS containing TFL-CSLU
Product Description: An electricity powered de Open, Classified |
GEX | None listed |
| Jun 6, 2025 | Olympus Corporation of the Americas Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Pro SuperPulsed Laser System
Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only);
Product Description: SOLTIVE Laser Systems use Open, Classified |
GEX | None listed |
| Jun 6, 2025 | Olympus Corporation of the Americas Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Premium SuperPulsed Laser System
Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only);
Software Version: N/A
Product Description: Open, Classified |
GEX | None listed |
| Jun 6, 2025 | Olympus Corporation of the Americas Brand Name: Powered Laser Surgical Instrument
Product Name: Soltive SuperPulsed Laser Fibers - Single Use
Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL- Open, Classified |
GEX | None listed |
| Jun 6, 2025 | Olympus Corporation of the Americas Brand Name: Powered Laser Surgical Instrument
Product Name: Soltive Reusable Laser Fibers
Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan O Open, Classified |
GEX | None listed |
| May 1, 2025 | Olympus Corporation of the Americas Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Pro SuperPulsed Laser System
Model/Catalog Numbers: TFL-SLS, TFL-PLS
Product Description: SOLTIVE Laser Systems use technology to in Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.