Cleared Traditional

K843594 - AIRVIT MODEL 8500

K843594 is an FDA 510(k) clearance for AIRVIT MODEL 8500, manufactured by Lasermed Corp.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K843594 · Lasermed Corp. · Ophthalmic device
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Apr 1985
Decision
211d
Days
Class 2
Risk

K843594 is an FDA 510(k) clearance for the AIRVIT MODEL 8500. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Lasermed Corp. (Newport Beach, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 211 days - an extended review 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: 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 Lasermed Corp. devices

FDA 510(k) Submission Details - K843594

510(k) Number K843594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date April 11, 1985
Days to Decision 211 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 110d · This submission: 211d
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 K843594.
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · CooperVision, Inc. · Aug 1985
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
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K844715 · Optical Micro Systems, Inc. · Jan 1985
MVS XII
K842793 · Medical Instrument Development Laboratories, Inc. · Dec 1984