The following data is part of a premarket notification filed by Avex Industries Ltd. with the FDA for Phototherapeutix Model 1600b.
| Device ID | K935526 |
| 510k Number | K935526 |
| Device Name: | PHOTOTHERAPEUTIX MODEL 1600B |
| 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 | 1995-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B343B1600 | K935526 | 000 |