Cleared Traditional

BURR, CORNEAL, BATTERY-POWERED (K950520) - FDA 510(k) Clearance

Class I Ophthalmic device.

K950520 · Aaron Medical Industries · Ophthalmic device
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May 1995
Decision
85d
Days
Class 1
Risk

K950520 is an FDA 510(k) clearance for the BURR, CORNEAL, BATTERY-POWERED. Classified as Burr, Corneal, Battery-powered (product code HOG), Class I - General Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aaron Medical Industries devices

Submission Details

510(k) Number K950520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date May 02, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.