Cleared Traditional

K844715 - VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY

K844715 is an FDA 510(k) clearance for VISC-X VITREOUS ASPIRATING & CUTTING IN..., manufactured by Optical Micro Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K844715 · Optical Micro Systems, Inc. · Ophthalmic device
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Jan 1985
Decision
56d
Days
Class 2
Risk

K844715 is an FDA 510(k) clearance for the VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on January 22, 1985 after a review of 56 days - a notably fast clearance cycle.

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: 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 Optical Micro Systems, Inc. devices

FDA 510(k) Submission Details - K844715

510(k) Number K844715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date January 22, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
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 K844715.
VISITEC 2 MICRON FLUID FILTER
K853135 · Visitec Co. · Aug 1985
COMBINED MVS SYSTEMS
K851610 · Medical Instrument Development Laboratories, Inc. · Jul 1985
I/A HANDPIECE
K850857 · Medical Instrument Development Laboratories, Inc. · Mar 1985
MVS XII
K842793 · Medical Instrument Development Laboratories, Inc. · Dec 1984
INFUSION ASPIRATION VITRECTOMY SYS
K843391 · Medical Instrument Development Laboratories, Inc. · Dec 1984
O.M.S. GUILLOTINE CUTTER
K844374 · Optical Micro Systems, Inc. · Dec 1984