510(k) K200300 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
VivAer Stylus
| Applicant | Aerin Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 13, 2020 |
| Received | Feb 6, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2025 | Aerin Medical, Inc. Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.