The following data is part of a premarket notification filed by Med-genesis, Inc. with the FDA for Med-genesis Patient Laser Eye Shield.
| Device ID | K934459 |
| 510k Number | K934459 |
| Device Name: | MED-GENESIS PATIENT LASER EYE SHIELD |
| Classification | Shield, Eye, Radiological |
| Applicant | MED-GENESIS, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook MED-GENESIS, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | IWS |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-10 |
| Decision Date | 1994-02-22 |