The following data is part of a premarket notification filed by Alma Lasers, Ltd. with the FDA for The Alma Hybrid Laser System.
| Device ID | K203441 |
| 510k Number | K203441 |
| Device Name: | The Alma Hybrid Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Alma Lasers, Ltd. 18 Haharash Street, North Industrial Park Caesarea Ha Zafon, IL 3079895 |
| Contact | Avi Hirshnzon |
| Correspondent | Avi Hirshnzon Alma Lasers, Ltd. 18 Haharash Street, North Industrial Park Caesarea Ha Zafon, IL 3079895 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110122147 | K203441 | 000 |
| 17290110122130 | K203441 | 000 |
| 17290110122123 | K203441 | 000 |
| 17290110122116 | K203441 | 000 |
| 17290110122109 | K203441 | 000 |
| 17290110122093 | K203441 | 000 |