The following data is part of a premarket notification filed by Alma Lasers, Ltd. with the FDA for Alma Diode Tabletop Laser.
| Device ID | K212073 |
| 510k Number | K212073 |
| Device Name: | Alma Diode Tabletop Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Alma Lasers, Ltd. 18 Haharash Street, North Industrial Park Caesarea, IL 3079895 |
| Contact | Avi Hirshnzon |
| Correspondent | Connie Hoy Hoy & Associates Regulatory Consulting 1830 Bonnie Way Sacramento, CA 95825 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110123069 | K212073 | 000 |
| 07290110123086 | K212073 | 000 |
| 07290110123079 | K212073 | 000 |