The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Pelleve Glidesafe Non-ablative Wrinkle Treatment System Model Pelleve Glidesafe.
| Device ID | K102698 |
| 510k Number | K102698 |
| Device Name: | PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE |
| 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 | 2010-09-20 |
| Decision Date | 2011-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108328 | K102698 | 000 |
| 00841494105303 | K102698 | 000 |
| 00841494105310 | K102698 | 000 |
| 00841494105327 | K102698 | 000 |
| 00841494105334 | K102698 | 000 |
| 00841494108113 | K102698 | 000 |
| 00841494108120 | K102698 | 000 |
| 00841494108144 | K102698 | 000 |
| 00841494108168 | K102698 | 000 |
| 00841494108182 | K102698 | 000 |
| 00841494108281 | K102698 | 000 |
| 00841494108298 | K102698 | 000 |
| 00841494108304 | K102698 | 000 |
| 00841494108311 | K102698 | 000 |
| 00841494105075 | K102698 | 000 |