Cleared Traditional

K050856 - LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM

K050856 is an FDA 510(k) clearance for LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM, manufactured by Ophthocare , Ltd.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K050856 · Ophthocare , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
56d
Days
Class 1
Risk

K050856 is an FDA 510(k) clearance for the LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Ophthocare , Ltd. (Ramat-Gan, IL). The FDA issued a Cleared decision on May 31, 2005 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050856

510(k) Number K050856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 48
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K050856.
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
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ARCTIC PREMIER SERIES
K944700 · Sungold Eyewear, Inc. · Dec 1994
GOGGLE SAFEGUARD
K944857 · Sellstrom Mfg. Co. · Dec 1994
SHIELD, EYE, OPHTHALMIC
K945351 · Taiwan Eva Industrial Co., Inc. · Dec 1994
MAKROLON 2405 GOGGLES (LIGHT AND DARK)
K945346 · Universal Massage & Tanning, Inc. · Nov 1994
K050856 · LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
Download PDF FDA Summary Ophthocare , Ltd.