The following data is part of a premarket notification filed by Visitec Co. with the FDA for Soft Corneal Light Shield.
| Device ID | K896681 |
| 510k Number | K896681 |
| Device Name: | SOFT CORNEAL LIGHT SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | Liaquat Allarakhia |
| Correspondent | Liaquat Allarakhia VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-27 |
| Decision Date | 1990-01-11 |