The following data is part of a premarket notification filed by Alma Lasers, Inc. with the FDA for Modified Alma Lasers Family Of Accent Radiofrequency (rf) System.
| Device ID | K101147 |
| 510k Number | K101147 |
| Device Name: | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | ALMA LASERS, INC. 485 HALF DAY RD. SUITE #100 Buffalo Grove, IL 60089 |
| Contact | Tatiana Epstein |
| Correspondent | Tatiana Epstein ALMA LASERS, INC. 485 HALF DAY RD. SUITE #100 Buffalo Grove, IL 60089 |
| 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 | 2010-04-23 |
| Decision Date | 2011-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110120112 | K101147 | 000 |
| 17290110122161 | K101147 | 000 |
| 17290110122178 | K101147 | 000 |
| 17290110122185 | K101147 | 000 |
| 17290110122192 | K101147 | 000 |
| 17290110122208 | K101147 | 000 |
| 17290110122086 | K101147 | 000 |
| 17290110121782 | K101147 | 000 |
| 17290110121805 | K101147 | 000 |
| 17290110121720 | K101147 | 000 |
| 17290110121706 | K101147 | 000 |
| 17290110121713 | K101147 | 000 |
| 17290110120082 | K101147 | 000 |
| 17290110120099 | K101147 | 000 |
| 17290110120105 | K101147 | 000 |
| 17290110122154 | K101147 | 000 |