The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Visualase Thermal Therapy System.
| Device ID | K071328 |
| 510k Number | K071328 |
| Device Name: | VISUALASE THERMAL THERAPY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 -4185 |
| Contact | Matthew Fox |
| Correspondent | Matthew Fox BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 -4185 |
| Product Code | GEX |
| Subsequent Product Code | FRN |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-11 |
| Decision Date | 2007-08-31 |
| Summary: | summary |