510(k) K142286 ยท GEX Powered Laser Surgical Instrument
NS3000 Holmium Laser System
| Applicant | New Star Lasers, Inc., Roseville CA, US |
| Decision | Substantially Equivalent, Oct 31, 2014 |
| Received | Aug 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | New Star Lasers, Inc. StoneLight 30 Laser System (NS3000).
For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis 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.