Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K211401 |
Device Name |
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) |
Applicant |
Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Applicant Contact |
Julie Acker |
Correspondent |
Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Correspondent Contact |
Julie Acker |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/06/2021 |
Decision Date | 06/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|