Cleared Traditional

K933503 - PRO-PHACO HANDPIECE

K933503 is the FDA 510(k) clearance for PRO-PHACO HANDPIECE by M. Imonti and Associates Inc.,. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K933503 · M. Imonti and Associates Inc., · Ophthalmic device
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Jan 1994
Decision
171d
Days
Class 2
Risk

K933503 is an FDA 510(k) clearance for the PRO-PHACO HANDPIECE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by M. Imonti and Associates Inc., (San Juan Capistrano, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 171 days - an extended review 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: 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 M. Imonti and Associates Inc., devices

Submission Details

510(k) Number K933503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date January 06, 1994
Days to Decision 171 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
61d slower than avg
Panel avg: 110d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K933503.
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STORZ PHACO AND FRAG HANDPIECES
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K890635 · CooperVision, Inc. · May 1989