Cleared Traditional

K945583 - OCUSYSTEM(ART)

K945583 is an FDA 510(k) clearance for OCUSYSTEM(ART), manufactured by Arent Fox. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K945583 · Arent Fox · Ophthalmic device
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Feb 1995
Decision
91d
Days
Class 2
Risk

K945583 is an FDA 510(k) clearance for the OCUSYSTEM(ART). Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Arent Fox (Washington, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Arent Fox devices

FDA 510(k) Submission Details - K945583

510(k) Number K945583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date February 13, 1995
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 113
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K945583.
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K946227 · Storz Instrument Co. · Mar 1995
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
K944994 · Chiron Vision Corp. · Mar 1995
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994
P4000 PHACOEMULSIFIER
K931354 · American Optical Corp. · Feb 1994
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994