Cleared Traditional

K080776 - GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72

K080776 is an FDA 510(k) clearance for GILRAS SLIT LAMP, manufactured by Us Ophthalmic, LLC. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K080776 · Us Ophthalmic, LLC · Ophthalmic device
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Sep 2008
Decision
174d
Days
Class 2
Risk

K080776 is an FDA 510(k) clearance for the GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Us Ophthalmic, LLC (Miami, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 174 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Us Ophthalmic, LLC devices

FDA 510(k) Submission Details - K080776

510(k) Number K080776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2008
Decision Date September 09, 2008
Days to Decision 174 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 110d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 45
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K080776.
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K063640 · Kowa Co. , Ltd. · Dec 2006
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K012873 · Bausch & Lomb, Inc. · Nov 2001
IOLMASTER
K993357 · Carl Zeiss, Inc. · Mar 2000