The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Lasers Accent B-shape Massager Handpiece/module.
| Device ID | K082622 |
| 510k Number | K082622 |
| Device Name: | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566 |
| Product Code | NUV |
| Subsequent Product Code | GEI |
| Subsequent Product Code | ISA |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-01-12 |
| Summary: | summary |