The following data is part of a premarket notification filed by Tria Beauty, Inc. with the FDA for Tria Fan System.
| Device ID | K130459 |
| 510k Number | K130459 |
| Device Name: | TRIA FAN SYSTEM |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| 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 | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5863426 | K130459 | 000 |
| B58613752 | K130459 | 000 |