The following data is part of a premarket notification filed by Theralase Inc. with the FDA for Theralase Tlc-1000 Therapeutic Medical Laser System.
| Device ID | K050342 |
| 510k Number | K050342 |
| Device Name: | THERALASE TLC-1000 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. 600 ALDEN ROAD SUITE 101 Markham, Ontario, CA L3r 0e7 |
| Contact | Roger White |
| Correspondent | Roger White THERALASE INC. 600 ALDEN ROAD SUITE 101 Markham, Ontario, CA L3r 0e7 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-07-11 |
| Summary: | summary |