The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for The Alma Opus System, Colibri Applicator And Tips.
| Device ID | K201520 |
| 510k Number | K201520 |
| Device Name: | The Alma Opus System, Colibri Applicator And Tips |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2021-10-27 |