Cleared Traditional

K924033 - ALTEX MODEL UST-3000E

K924033 is an FDA 510(k) clearance for ALTEX MODEL UST-3000E, manufactured by Optro-Mechanics (Usa) Corp.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K924033 · Optro-Mechanics (Usa) Corp. · Ophthalmic device
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Nov 1992
Decision
86d
Days
Class 2
Risk

K924033 is an FDA 510(k) clearance for the ALTEX MODEL UST-3000E. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Optro-Mechanics (Usa) Corp. (Pearl River, US). The FDA issued a Cleared decision on November 5, 1992 after a review of 86 days - a notably fast clearance cycle.

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: 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 Optro-Mechanics (Usa) Corp. devices

FDA 510(k) Submission Details - K924033

510(k) Number K924033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date November 05, 1992
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 198
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