Cleared Traditional

K820008 - VERSATOME I

K820008 is an FDA 510(k) clearance for VERSATOME I, manufactured by Alphamedix, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K820008 · Alphamedix, Inc. · Ophthalmic device
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Feb 1982
Decision
49d
Days
Class 2
Risk

K820008 is an FDA 510(k) clearance for the VERSATOME I. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Alphamedix, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 22, 1982 after a review of 49 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 Alphamedix, Inc. devices

FDA 510(k) Submission Details - K820008

510(k) Number K820008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1982
Decision Date February 22, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
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 93
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K820008.
BAILEY ASPIRATOR/IRRIGATOR
K831584 · Medical Instrument Development Laboratories, Inc. · Aug 1983
DORC COMPACT MICRO SURGICAL SYSTEM
K830216 · Jedmed Instrument Co. · Mar 1983
COOPER VISION I/A SYSTEM III MODEL 1500
K822220 · CooperVision, Inc. · Oct 1982
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
K813274 · Optical Micro Systems, Inc. · Feb 1982
VITRE CON
K820026 · Medical Instrument Development Laboratories, Inc. · Feb 1982
OMS INFUSION-ASPIRATION HANDLE
K813500 · Optical Micro Systems, Inc. · Feb 1982