The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Soprano Ice Multi-application & Multi-technology Platform.
| Device ID | K140009 |
| 510k Number | K140009 |
| Device Name: | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM |
| 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 | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121591 | K140009 | 000 |
| 17290110120662 | K140009 | 000 |
| 17290110120655 | K140009 | 000 |
| 17290110120648 | K140009 | 000 |
| 17290110120631 | K140009 | 000 |
| 17290110120624 | K140009 | 000 |
| 17290110120617 | K140009 | 000 |
| 17290110120600 | K140009 | 000 |
| 17290110120594 | K140009 | 000 |
| 17290110120679 | K140009 | 000 |
| 17290110120686 | K140009 | 000 |
| 17290110121492 | K140009 | 000 |
| 17290110121393 | K140009 | 000 |
| 17290110121386 | K140009 | 000 |
| 17290110121010 | K140009 | 000 |
| 17290110121003 | K140009 | 000 |
| 17290110120716 | K140009 | 000 |
| 17290110120709 | K140009 | 000 |
| 17290110120693 | K140009 | 000 |
| 17290110120587 | K140009 | 000 |