The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Diode Tabletop Laser.
| Device ID | K140005 |
| 510k Number | K140005 |
| Device Name: | ALMA DIODE TABLETOP LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LASERS LTD. 26 REBECCA CT Homosassa, FL 34446 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor ALMA LASERS LTD. 26 REBECCA CT Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121324 | K140005 | 000 |
| 17290110121317 | K140005 | 000 |
| 17290110121300 | K140005 | 000 |
| 17290110120808 | K140005 | 000 |