The following data is part of a premarket notification filed by Alma Lasers, Inc. with the FDA for Modified Alma Lasers Family Of Soprano Xl Multi-application Platmforms.
| Device ID | K102716 |
| 510k Number | K102716 |
| Device Name: | MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-21 |
| Decision Date | 2010-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110120990 | K102716 | 000 |