Cleared Traditional

AARON VAC 2 (K952558) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952558 · Aaron Medical Industries · Ophthalmic device
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Mar 1997
Decision
656d
Days
Class 2
Risk

K952558 is an FDA 510(k) clearance for the AARON VAC 2. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 656 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Aaron Medical Industries devices

Submission Details

510(k) Number K952558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date March 19, 1997
Days to Decision 656 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
546d slower than avg
Panel avg: 110d · This submission: 656d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKP Instrument, Vitreous Aspiration And Cutting, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.