510(k) K082834 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
| Applicant | Ellman Int'L, Inc., Oceanside NY, US |
| Decision | Substantially Equivalent, May 7, 2009 |
| Received | Sep 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2012 | Ellman International, Inc. Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablati Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.