The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Fuorecam.
| Device ID | K093705 |
| 510k Number | K093705 |
| Device Name: | FUORECAM |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222 Indianapolis, IN 46202 -4119 |
| Contact | Bart Collins |
| Correspondent | Bart Collins THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222 Indianapolis, IN 46202 -4119 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-01 |
| Decision Date | 2010-04-23 |
| Summary: | summary |