The following data is part of a premarket notification filed by Thor International with the FDA for Thor Vr Single Diode Laser Treatment Probe, Model 200 Mw Single Vr Diode Probe.
| Device ID | K070024 |
| 510k Number | K070024 |
| Device Name: | THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | THOR INTERNATIONAL 12101 CULLEN BLVD. SUITE A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich THOR INTERNATIONAL 12101 CULLEN BLVD. SUITE A Houston, TX 77047 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-05-16 |
| Summary: | summary |