Device Classification Name |
Powered Laser Surgical Instrument With Microbeam\Fractional Output
|
510(k) Number |
K110349 |
Device Name |
CLEAR+BRILLIANT LASER SYSTEM |
Applicant |
SOLTA MEDICAL, INC. |
25881 INDUSTRIAL BLVD. |
HAYWARD,
CA
94545
|
|
Applicant Contact |
KRISTINE FOSS |
Correspondent |
SOLTA MEDICAL, INC. |
25881 INDUSTRIAL BLVD. |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
KRISTINE FOSS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/07/2011 |
Decision Date | 05/03/2011 |
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
|