Cleared Traditional

LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM

K050856 · Ophthocare , Ltd. · Ophthalmic

May 2005

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K050856 is an FDA 510(k) clearance for the LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by Ophthocare , Ltd. (Ramat-Gan, IL). The FDA issued a Cleared decision on May 31, 2005, 56 days after receiving the submission on April 5, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K050856 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2005
Decision Date	May 31, 2005
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 886.4750