The following data is part of a premarket notification filed by Spectragenics, Inc. with the FDA for Tria Hair Removal Laser System.
| Device ID | K090820 |
| 510k Number | K090820 |
| Device Name: | TRIA HAIR REMOVAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRAGENICS, INC. 5880 W. LAS POSITAS BLVD SUITE 52 Pleasanton, CA 94588 -8522 |
| Contact | Tobin C Island |
| Correspondent | Tobin C Island SPECTRAGENICS, INC. 5880 W. LAS POSITAS BLVD SUITE 52 Pleasanton, CA 94588 -8522 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-26 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5863724 | K090820 | 000 |
| B5863271 | K090820 | 000 |
| B5863178 | K090820 | 000 |
| B5863175 | K090820 | 000 |
| B5863174 | K090820 | 000 |
| B5863725 | K090820 | 000 |
| B5863192 | K090820 | 000 |
| B5863159 | K090820 | 000 |