The following data is part of a premarket notification filed by Avex Industries Ltd. with the FDA for Phototherapeutix Model 2480ab.
| Device ID | K935525 |
| 510k Number | K935525 |
| Device Name: | PHOTOTHERAPEUTIX MODEL 2480AB |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | AVEX INDUSTRIES LTD. 3 DEPOT ST. P.O. BOX 230 Hudson Falls, NY 12839 |
| Contact | Ray Torrico |
| Correspondent | Ray Torrico AVEX INDUSTRIES LTD. 3 DEPOT ST. P.O. BOX 230 Hudson Falls, NY 12839 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1995-05-19 |