Cleared Traditional

K852404 - LASERSAFE EYE SHIELDS

K852404 is an FDA 510(k) clearance for LASERSAFE EYE SHIELDS, manufactured by Lasersafe, Inc.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K852404 · Lasersafe, Inc. · Ophthalmic device
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Oct 1985
Decision
120d
Days
Class 1
Risk

K852404 is an FDA 510(k) clearance for the LASERSAFE EYE SHIELDS. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Lasersafe, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 120 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 Lasersafe, Inc. devices

FDA 510(k) Submission Details - K852404

510(k) Number K852404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date October 04, 1985
Days to Decision 120 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 110d · This submission: 120d
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 16
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K852404.
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988
EYE GARD
K872000 · Treace Medical, Inc. · Jul 1987
HESSBURG LIGHT GUARD
K853035 · Visitec Co. · Dec 1985
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
K844761 · Medical Instrument Development Laboratories, Inc. · Dec 1984
STORZ UNIVERSAL EYE SHIELD
K841599 · Storz Instrument Co. · May 1984
NEONATE MASK FOR BABIES
K840444 · Richards Medical Co., Inc. · Mar 1984