The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Lasers Alex755 Module.
| Device ID | K090571 |
| 510k Number | K090571 |
| Device Name: | ALMA LASERS ALEX755 MODULE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LASERS LTD. 485 HALF DAY ROAD SUITE 100 Buffalo Grove, IL 60089 |
| Contact | Howard Kelly |
| Correspondent | Howard Kelly ALMA LASERS LTD. 485 HALF DAY ROAD SUITE 100 Buffalo Grove, IL 60089 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-08-13 |
| Summary: | summary |