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 |