Cleared Traditional

K972253 - P3 UNIVERSAL PHACO HANDPIECE

K972253 is an FDA 510(k) clearance for P3 UNIVERSAL PHACO HANDPIECE, manufactured by Odyssey Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K972253 · Odyssey Technologies, Inc. · Ophthalmic device
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Jul 1997
Decision
43d
Days
Class 2
Risk

K972253 is an FDA 510(k) clearance for the P3 UNIVERSAL PHACO HANDPIECE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Odyssey Technologies, Inc. (Temple City, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 43 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 Odyssey Technologies, Inc. devices

FDA 510(k) Submission Details - K972253

510(k) Number K972253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date July 29, 1997
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 110d · This submission: 43d
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 159
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K972253.
FRAG COMMANDER
K973749 · Scieran Technologies, Inc. · Dec 1997
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VISTA UNIVERSAL HANDPIECE
K972252 · Odyssey Technologies, Inc. · Jul 1997
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STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · Storz Instrument Co. · Jun 1997