Cleared Traditional

K923725 - OPHTHALMIC PHARCO NEEDLE

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

K923725 · Synergetics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Synergetics, Inc. devices

Submission Details

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
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.

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 70
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K923725.
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
K901686 · Nidek, Inc. · Jun 1990
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K890635 · CooperVision, Inc. · May 1989
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · CooperVision, Inc. · Jul 1987