510(k) K221306 ยท GEX Powered Laser Surgical Instrument
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
| Applicant | Gyrus Acmi, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Jan 27, 2023 |
| Received | May 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2024 | Olympus Corporation of the Americas Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue,
Model/Catalog Number: TFL-PLS Open, Classified |
GEX | None listed |
| Oct 18, 2024 | Olympus Corporation of the Americas Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue
Model/Catalog Number: TFL-SLS Open, Classified |
GEX | None listed |
| Aug 5, 2024 | Olympus Corporation of the Americas Soltive Premium SuperPulsed Laser System, Model TFL-PLS Open, Classified |
GEX | None listed |
| Aug 5, 2024 | Olympus Corporation of the Americas Soltive Pro SuperPulsed Laser System, Model TFL-SLS Open, Classified |
GEX | None listed |
| Aug 5, 2024 | Olympus Corporation of the Americas Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL Open, Classified |
GEX | None listed |
| Mar 27, 2024 | Olympus Corporation of the Americas SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) Open, Classified |
GEX | None listed |
| Mar 27, 2024 | Olympus Corporation of the Americas SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) Open, Classified |
GEX | None listed |
| Jan 12, 2024 | Olympus Corporation of the Americas SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.