510(k) K182604 ยท GEX Powered Laser Surgical Instrument
New Era
| Applicant | Step UP Skin Laser, LLC, New York NY, US |
| Decision | Substantially Equivalent, Nov 14, 2018 |
| Received | Sep 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2020 | Inova Lasers LLC Class IV New Era medical laser device Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.