Cleared Traditional

K853035 - HESSBURG LIGHT GUARD

K853035 is an FDA 510(k) clearance for HESSBURG LIGHT GUARD, manufactured by Visitec Co.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K853035

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 110d · This submission: 148d
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 9
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K853035.
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988
EYE GARD
K872000 · Treace Medical, Inc. · Jul 1987
STORZ UNIVERSAL EYE SHIELD
K841599 · Storz Instrument Co. · May 1984
NEONATE MASK FOR BABIES
K840444 · Richards Medical Co., Inc. · Mar 1984
FOX EYE SHIELDS
K810098 · American Hospital Supply Corp. · Feb 1981