510(k) K183647 · GEX Powered Laser Surgical Instrument
SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories)
| Applicant | Olympus Surgical Technologies America, Southborough MA, US |
| Decision | Substantially Equivalent, Aug 9, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Olympus Corporation of the Americas SOLTIVE SuperPulsed Laser Fibers
Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS Open, Classified |
GEX | None listed |
| Jan 12, 2024 | Olympus Corporation of the Americas Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 Open, Classified |
GEX | None listed |
| Jan 12, 2024 | Olympus Corporation of the Americas Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC Open, Classified |
GEX | None listed |
| May 26, 2022 | Olympus Corporation of the Americas SOLTIVE SuperPulsed Laser Fibers,
Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber
Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber
Model # Labeled TFL-FBX2 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.