Cleared Traditional

K875107 - HEALTH CARE EYE PROTECTION

K875107 is an FDA 510(k) clearance for HEALTH CARE EYE PROTECTION, manufactured by Surgikos, Inc.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K875107 · Surgikos, Inc. · Ophthalmic device
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Mar 1988
Decision
98d
Days
Class 1
Risk

K875107 is an FDA 510(k) clearance for the HEALTH CARE EYE PROTECTION. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Surgikos, Inc. (Arlington, US). The FDA issued a Cleared decision on March 21, 1988 after a review of 98 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 Surgikos, Inc. devices

FDA 510(k) Submission Details - K875107

510(k) Number K875107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1987
Decision Date March 21, 1988
Days to Decision 98 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
12d faster than avg
Panel avg: 110d · This submission: 98d
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 13
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K875107.
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
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