The following data is part of a premarket notification filed by Iris Optical, Inc. with the FDA for Visard Frames.
| Device ID | K942478 |
| 510k Number | K942478 |
| Device Name: | VISARD FRAMES |
| Classification | Frame, Spectacle |
| Applicant | IRIS OPTICAL, INC. 6405 N.W. 36 ST., #116 Miami, FL 33166 |
| Contact | Hernan Pineda |
| Correspondent | Hernan Pineda IRIS OPTICAL, INC. 6405 N.W. 36 ST., #116 Miami, FL 33166 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1994-08-05 |