Cleared Traditional

K923725 - OPHTHALMIC PHARCO NEEDLE

K923725 is an FDA 510(k) clearance for OPHTHALMIC PHARCO NEEDLE, manufactured by Synergetics, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K923725 · Synergetics, Inc. · Ophthalmic device
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Mar 1993
Decision
234d
Days
Class 2
Risk

K923725 is an FDA 510(k) clearance for the OPHTHALMIC PHARCO NEEDLE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 234 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.

FDA 510(k) Submission Details - K923725

510(k) Number K923725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date March 18, 1993
Days to Decision 234 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
124d slower than avg
Panel avg: 110d · This submission: 234d
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 271
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K923725.
STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
K926512 · Storz · Sep 1993
PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE
K925631 · Chiron Intraoptics · Jul 1993
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993
AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
K925254 · Allergan Medical Optics · Jan 1993
AMO ELITE
K924235 · Allergan Medical Optics · Dec 1992
ALTEX MODEL UST-3000E
K924033 · Optro-Mechanics (Usa) Corp. · Nov 1992
K923725 · OPHTHALMIC PHARCO NEEDLE
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