The following data is part of a premarket notification filed by Phoenix Thera-lase Systems, Llc with the FDA for Phoenix Thera-lase System.
| Device ID | K151521 |
| 510k Number | K151521 |
| Device Name: | Phoenix Thera-Lase System |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | PHOENIX THERA-LASE SYSTEMS, LLC 5454 LA SIERRA DRIVE, SUITE 203 Dallas, TX 75231 |
| Contact | Gary Bellinger |
| Correspondent | Diane Rutherford KEN BLOCK CONSULTING 1201 RICHARDSON DRIVE, SUITE 280 Richardson, TX 75080 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-05 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860012325023 | K151521 | 000 |
| 00086001232503 | K151521 | 000 |
| 00860012594924 | K151521 | 000 |
| 00860012594917 | K151521 | 000 |
| 00860012594900 | K151521 | 000 |
| 00860012325092 | K151521 | 000 |
| 00860012325085 | K151521 | 000 |
| 00860012325078 | K151521 | 000 |
| 00860012325054 | K151521 | 000 |
| 00008612325047 | K151521 | 000 |
| 00860012310906 | K151521 | 000 |
| 00860012310913 | K151521 | 000 |
| 00860012310920 | K151521 | 000 |
| 00860012325016 | K151521 | 000 |
| 00860012325009 | K151521 | 000 |
| 00860012310999 | K151521 | 000 |
| 00860012310982 | K151521 | 000 |
| 00860012310975 | K151521 | 000 |
| 00860012310968 | K151521 | 000 |
| 00860012310951 | K151521 | 000 |
| 00860012310944 | K151521 | 000 |
| 00860012310937 | K151521 | 000 |
| 00860012325030 | K151521 | 000 |