The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Lasers Family Of Accent Radiofrequency (rf) Systems, Models: Accent, Accent Xl.
| Device ID | K072699 |
| 510k Number | K072699 |
| Device Name: | ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Contact | A Worden |
| Correspondent | A Worden ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-24 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121362 | K072699 | 000 |
| 17290110120174 | K072699 | 000 |
| 17290110120167 | K072699 | 000 |
| 17290110120150 | K072699 | 000 |
| 17290110120143 | K072699 | 000 |
| 17290110120136 | K072699 | 000 |
| 17290110120129 | K072699 | 000 |
| 17290110120075 | K072699 | 000 |
| 17290110120068 | K072699 | 000 |
| 17290110120051 | K072699 | 000 |
| 17290110120044 | K072699 | 000 |
| 17290110120037 | K072699 | 000 |
| 17290110120020 | K072699 | 000 |
| 17290110120013 | K072699 | 000 |
| 17290110120181 | K072699 | 000 |
| 17290110120198 | K072699 | 000 |
| 17290110120204 | K072699 | 000 |
| 17290110121348 | K072699 | 000 |
| 17290110121331 | K072699 | 000 |
| 17290110121294 | K072699 | 000 |
| 17290110120877 | K072699 | 000 |
| 17290110120860 | K072699 | 000 |
| 17290110120853 | K072699 | 000 |
| 17290110120846 | K072699 | 000 |
| 17290110120839 | K072699 | 000 |
| 17290110120822 | K072699 | 000 |
| 17290110120242 | K072699 | 000 |
| 17290110120235 | K072699 | 000 |
| 17290110120228 | K072699 | 000 |
| 17290110120211 | K072699 | 000 |
| 17290110120006 | K072699 | 000 |