510(k) K211401 ยท GEX Powered Laser Surgical Instrument
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
| Applicant | Gyrus Acmi, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Jun 3, 2021 |
| Received | May 6, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2021 | Olympus Corporation of the Americas Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft t Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.