The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Visualase Thermal Therapy System.
| Device ID | K081656 |
| 510k Number | K081656 |
| Device Name: | VISUALASE THERMAL THERAPY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 -4185 |
| Contact | Roger Mcnichols |
| Correspondent | Roger Mcnichols BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 -4185 |
| Product Code | LLZ |
| Subsequent Product Code | FRN |
| Subsequent Product Code | GEX |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-12 |
| Decision Date | 2008-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169878181 | K081656 | 000 |
| 00643169792890 | K081656 | 000 |
| 00643169655935 | K081656 | 000 |
| 00643169590076 | K081656 | 000 |
| 00643169584440 | K081656 | 000 |