Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K223647 |
Device Name |
CLEAR+BRILLIANT TOUCH® Laser System |
Applicant |
Solta Medical, Inc. |
11720 North Creek Pkway N. |
Suite 100 |
Bothell,
WA
98011
|
|
Applicant Contact |
Aditi Chaubal |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/06/2022 |
Decision Date | 12/29/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|