The following data is part of a premarket notification filed by Alma Ltd with the FDA for Alma Diode Tabletop Laser.
| Device ID | K160952 |
| 510k Number | K160952 |
| Device Name: | Alma Diode Tabletop Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LTD 14 Halamish St Caesarea Industrial Park Caesarea, IL 38900 |
| Contact | Ariela Albalak |
| Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110120723 | K160952 | 000 |