Cleared Traditional

K954746 - PHACO TIP

K954746 is an FDA 510(k) clearance for PHACO TIP, manufactured by U.S. Iol, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K954746 · U.S. Iol, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
87d
Days
Class 2
Risk

K954746 is an FDA 510(k) clearance for the PHACO TIP. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by U.S. Iol, Inc. (Temple City, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 87 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 U.S. Iol, Inc. devices

FDA 510(k) Submission Details - K954746

510(k) Number K954746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date January 11, 1996
Days to Decision 87 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
23d faster than avg
Panel avg: 110d · This submission: 87d
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 167
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K954746.
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
K955901 · Storz Instrument Co. · Mar 1996
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K955789 · Alcon Laboratories · Mar 1996
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
K955245 · Mentor O & O, Inc. · Feb 1996
SURGIN GENISIS HANDPIECE
K954238 · Surgin Surgical Instrumentation, Inc. · Dec 1995
STORZ I/A HANDPIECES
K951463 · Storz Instrument Co. · Oct 1995
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
K944993 · Chiron Vision Corp. · Oct 1995