The following data is part of a premarket notification filed by Theralase Inc. with the FDA for Tlc-2000 Therapeutic Medical Laser System.
| Device ID | K151816 |
| 510k Number | K151816 |
| Device Name: | TLC-2000 Therapeutic Medical Laser System |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | Theralase Inc. 1945 Queen Street East Toronto, CA |
| Contact | Roger Dumoulin-white |
| Correspondent | Roger Dumoulin-white Theralase Inc. 1945 Queen Street East Toronto, CA |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627987397475 | K151816 | 000 |