The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Lasers Soprano Xl Multi-application Platform.
| Device ID | K083848 |
| 510k Number | K083848 |
| Device Name: | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LASERS LTD. HALAMISH ST. POB 3021 INDUSTRIAL PARK Caesarea, IL 38900 |
| Contact | Tatiana Epstein |
| Correspondent | Tatiana Epstein ALMA LASERS LTD. HALAMISH ST. POB 3021 INDUSTRIAL PARK Caesarea, IL 38900 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110120983 | K083848 | 000 |