Cleared Traditional

K945493 - OPHTHALMIC CAUTERY

K945493 is an FDA 510(k) clearance for OPHTHALMIC CAUTERY, manufactured by Aaron Medical Industries. The device is a Class 2 Ophthalmic device with product code HQP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945493 · Aaron Medical Industries · Ophthalmic device
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Jan 1995
Decision
90d
Days
Class 2
Risk

K945493 is an FDA 510(k) clearance for the OPHTHALMIC CAUTERY. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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 Aaron Medical Industries devices

FDA 510(k) Submission Details - K945493

510(k) Number K945493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date January 30, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQP Device Classification - Class 2, Special Controls

Product Code HQP Unit, Cautery, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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.

Regulatory Peers - HQP Unit, Cautery, Thermal, Battery-powered

All 14
Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K945493.
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
K945761 · Aaron Medical Industries · Apr 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE
K945762 · Aaron Medical Industries · Feb 1995
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP
K945763 · Aaron Medical Industries · Feb 1995
ELECTROCAUTERY SYSTEM MODEL 1980
K933079 · Pmt Corp. · Feb 1994
OPTHERM FINE TIP
K840425 · Suncoast Medical Manufacturers, Inc. · May 1984
OPTHERM EXTRA FINE TIP
K840426 · Suncoast Medical Manufacturers, Inc. · May 1984