Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K201520 |
Device Name |
The Alma Opus System, Colibri Applicator and Tips |
Applicant |
Alma Lasers Inc. |
485 Half Day Rd Ste 100 |
Buffalo Grove,
IL
60089
|
|
Applicant Contact |
Jessica Rivera-Montejo |
Correspondent |
Kathy Maynor Consulting |
26 Rebecca Ct |
Homosassa,
FL
34446
|
|
Correspondent Contact |
Kathy Maynor |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/08/2020 |
Decision Date | 10/27/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|