| Device Classification Name |
over-the-counter powered light based laser for acne
|
| 510(k) Number |
K160821 |
| Device Name |
Tria Sapphire |
| Applicant |
| TRIA BEAUTY, INC. |
| 4160 Dublin Blvd., Ste 200 |
|
dublin,
CA
94568
|
|
| Applicant Contact |
heather tanner |
| Correspondent |
| HOGAN LOVELLS US LLP |
| 555 THIRTEENTH STREET NW |
|
washington,
DC
20004
|
|
| Correspondent Contact |
jonathan kahan |
| Regulation Number | 878.4810
|
| Classification Product Code |
|
| Date Received | 03/24/2016 |
| Decision Date | 06/15/2016 |
| 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
|