The following data is part of a premarket notification filed by Tria Beauty, Inc. with the FDA for Tria Laser Hair Removal System.
| Device ID | K120737 |
| 510k Number | K120737 |
| Device Name: | TRIA LASER HAIR REMOVAL SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIA BEAUTY, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan 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 | 2012-03-09 |
| Decision Date | 2012-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5863600 | K120737 | 000 |
| B5863634 | K120737 | 000 |