| 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
|
|---|