Cleared Traditional

K972063 - WHITTINGHAM ULTRACLEAN PHACO HANDPIECE

K972063 is an FDA 510(k) clearance for WHITTINGHAM ULTRACLEAN PHACO HANDPIECE, manufactured by William F. Whittingham. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K972063 · William F. Whittingham · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
175d
Days
Class 2
Risk

K972063 is an FDA 510(k) clearance for the WHITTINGHAM ULTRACLEAN PHACO HANDPIECE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by William F. Whittingham (Foothill Ranch, US). The FDA issued a Cleared decision on November 25, 1997 after a review of 175 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 William F. Whittingham devices

FDA 510(k) Submission Details - K972063

510(k) Number K972063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1997
Decision Date November 25, 1997
Days to Decision 175 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 110d · This submission: 175d
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 K972063.
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FRAG COMMANDER
K973749 · Scieran Technologies, Inc. · Dec 1997
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K972253 · Odyssey Technologies, Inc. · Jul 1997
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · Paradigm Medical Industries, Inc. · Jul 1997