The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Non-ablative Wrinkle Treatent Handpiece Modle Pelleve'.
| Device ID | K101967 |
| 510k Number | K101967 |
| Device Name: | NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
| Contact | Jonathan Achenbach |
| Correspondent | Jonathan Achenbach ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-13 |
| Decision Date | 2010-08-12 |
| Summary: | summary |