Cleared Traditional

K023939 - VELOCITY ADVANTAGE

K023939 is an FDA 510(k) clearance for VELOCITY ADVANTAGE, manufactured by Visioncare Devices, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K023939 · Visioncare Devices, Inc. · Ophthalmic device
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Apr 2003
Decision
142d
Days
Class 2
Risk

K023939 is an FDA 510(k) clearance for the VELOCITY ADVANTAGE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Visioncare Devices, Inc. (Redding, US). The FDA issued a Cleared decision on April 17, 2003 after a review of 142 days - within the typical 510(k) review window.

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: 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 Visioncare Devices, Inc. devices

FDA 510(k) Submission Details - K023939

510(k) Number K023939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2002
Decision Date April 17, 2003
Days to Decision 142 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
32d slower than avg
Panel avg: 110d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-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.

Regulatory Peers - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K023939.
VERSAVIT
K121675 · Synergetics, Inc. · Jun 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170 · Visioncare Devices, Inc. · May 2012
ULTIMATE VIT ENHAMCER (UVE)
K102222 · Medical Instrument Development Laboratories, Inc. · Apr 2011
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K020911 · Medical Instrument Development Laboratories, Inc. · Apr 2002
VIT ENHANCER
K992943 · Medical Instrument Development Laboratories, Inc. · Dec 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
K990292 · Ophthalmic Consultants, Inc. · Nov 1999