Cleared Traditional

K962989 - AMOILS EPITHELIAL SCRUBBER

K962989 is an FDA 510(k) clearance for AMOILS EPITHELIAL SCRUBBER, manufactured by S. Percy Amoils. The device is a Class 1 Ophthalmic device with product code HOG cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K962989 · S. Percy Amoils · Ophthalmic device
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Jan 1997
Decision
161d
Days
Class 1
Risk

K962989 is an FDA 510(k) clearance for the AMOILS EPITHELIAL SCRUBBER. Classified as Burr, Corneal, Battery-powered (product code HOG), Class I - General Controls.

Submitted by S. Percy Amoils (Chicago, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4070 - 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 S. Percy Amoils devices

FDA 510(k) Submission Details - K962989

510(k) Number K962989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1996
Decision Date January 09, 1997
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

HOG Device Classification - Class 1, General Controls

Product Code HOG Burr, Corneal, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
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.