The following data is part of a premarket notification filed by Dioptics Medical Products, Inc. with the FDA for Solarshield Clips.
| Device ID | K925531 |
| 510k Number | K925531 |
| Device Name: | SOLARSHIELD CLIPS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | DIOPTICS MEDICAL PRODUCTS, INC. 51 ZACA LN. San Luis Obispo, CA 93401 |
| Contact | Lee Langley |
| Correspondent | Lee Langley DIOPTICS MEDICAL PRODUCTS, INC. 51 ZACA LN. San Luis Obispo, CA 93401 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1994-02-22 |