Cleared Traditional

K944993 - IOLAB.SITE CD PHACOEMULSIFICATION MODULE

K944993 is the FDA 510(k) clearance for IOLAB.SITE CD PHACOEMULSIFICATION MODULE by Chiron Vision Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K944993 · Chiron Vision Corp. · Ophthalmic device
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Oct 1995
Decision
365d
Days
Class 2
Risk

K944993 is an FDA 510(k) clearance for the IOLAB.SITE CD PHACOEMULSIFICATION MODULE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on October 12, 1995 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K944993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1994
Decision Date October 12, 1995
Days to Decision 365 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
255d slower than avg
Panel avg: 110d · This submission: 365d
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 98
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K944993.
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
K955901 · Storz Instrument Co. · Mar 1996
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K955789 · Alcon Laboratories · Mar 1996
STORZ I/A HANDPIECES
K951463 · Storz Instrument Co. · Oct 1995
IOLAB/SITE PERISTALTIC MODULE
K944995 · Chiron Vision Corp. · Oct 1995
PHACO TIP
K950881 · American Optical Corp. · Sep 1995
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K952213 · Alcon Laboratories · Aug 1995