Cleared Traditional

K853035 - HESSBURG LIGHT GUARD (FDA 510(k) Clearance)

Class I Ophthalmic device.

K853035 · Visitec Co. · Ophthalmic device
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Dec 1985
Decision
148d
Days
Class 1
Risk

K853035 is an FDA 510(k) clearance for the HESSBURG LIGHT GUARD. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 148 days - within the typical 510(k) review window.

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: 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 Visitec Co. devices

Submission Details

510(k) Number K853035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1985
Decision Date December 13, 1985
Days to Decision 148 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.