The following data is part of a premarket notification filed by Ophthocare Ltd. with the FDA for Lcg (liquide Crystal Glasses) System.
| Device ID | K050856 |
| 510k Number | K050856 |
| Device Name: | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | OPHTHOCARE LTD. 11 MENACHEM BEGIN ST. Ramat-gan, IL 52521 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz OPHTHOCARE LTD. 11 MENACHEM BEGIN ST. Ramat-gan, IL 52521 |
| Product Code | HOY |
| Subsequent Product Code | HQG |
| Subsequent Product Code | HQY |
| Subsequent Product Code | HQZ |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-05 |
| Decision Date | 2005-05-31 |
| Summary: | summary |