The following data is part of a premarket notification filed by Tria Beauty, Inc. with the FDA for Tria Acne Treatment System, Model Ats-1 Otc.
| Device ID | K090312 |
| 510k Number | K090312 |
| Device Name: | TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIA BEAUTY, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan TRIA BEAUTY, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2010-01-05 |
| Summary: | summary |