The following data is part of a premarket notification filed by Alma Lasers Ltd with the FDA for Alma Q.
| Device ID | K170850 |
| 510k Number | K170850 |
| Device Name: | Alma Q |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Alma Lasers LTD Halamish St Pob 3021 Industrial Park Caesarea, IL 3088900 |
| Contact | Rekha Anand |
| Correspondent | Rekha Anand Alma Lasers LTD Halamish St Pob 3021 Industrial Park Caesarea, IL 3088900 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-22 |
| Decision Date | 2017-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121478 | K170850 | 000 |
| 17290110121461 | K170850 | 000 |
| 17290110121423 | K170850 | 000 |