The following data is part of a premarket notification filed by Tanses Technologies Inc. with the FDA for Collagentex Rx-1.
| Device ID | K162022 |
| 510k Number | K162022 |
| Device Name: | Collagentex Rx-1 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | Tanses Technologies Inc. 4450 Highway 13 Fabreville, CA H7r 6e9 |
| Contact | Kirk Kiremitci |
| Correspondent | Kirk Kiremitci Tanses Technologies Inc. 4450 Highway 13 Fabreville, CA H7r 6e9 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-21 |
| Decision Date | 2016-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850056256407 | K162022 | 000 |