The following data is part of a premarket notification filed by Thor Intl. with the FDA for Thor Ddii 830cl3 Laser System.
| Device ID | K030226 |
| 510k Number | K030226 |
| Device Name: | THOR DDII 830CL3 LASER SYSTEM |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | THOR INTL. 12101 CULLEN BLVD #A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich THOR INTL. 12101 CULLEN BLVD #A Houston, TX 77047 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-22 |
| Decision Date | 2003-02-10 |
| Summary: | summary |