The following data is part of a premarket notification filed by Tanses Technologies Inc. with the FDA for Collagentex Rx-6.
| Device ID | K180585 |
| 510k Number | K180585 |
| Device Name: | Collagentex Rx-6 |
| 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 | 2018-03-05 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850056256445 | K180585 | 000 |