The following data is part of a premarket notification filed by Tria Beauty, Inc. with the FDA for Tria Sapphire.
| Device ID | K160821 |
| 510k Number | K160821 |
| Device Name: | Tria Sapphire |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | TRIA BEAUTY, INC. 4160 Dublin Blvd., Ste 200 Dublin, CA 94568 |
| Contact | Heather Tanner |
| Correspondent | Jonathan Kahan HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-24 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5863374 | K160821 | 000 |
| B5863386 | K160821 | 000 |