The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for The Alma Soprano Titanium.
| Device ID | K222064 |
| 510k Number | K222064 |
| Device Name: | The Alma Soprano Titanium |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Alma Lasers Inc. 485 Half Day Rd Ste 100 Buffalo Grove, IL 60089 |
| Contact | Jessica Rivera-Montejo |
| Correspondent | Kathy Maynor Kathy Maynor Consulting 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 | 2022-07-13 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121829 | K222064 | 000 |
| 17290110121812 | K222064 | 000 |