Cleared Traditional

K953959 - PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES

K953959 is an FDA 510(k) clearance for PHACO HANDPIECE FOR PHACO FRAGMENTATION..., manufactured by Microsurgical Technology, 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.

K953959 · Microsurgical Technology, Inc. · Ophthalmic device
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Nov 1995
Decision
87d
Days
Class 2
Risk

K953959 is an FDA 510(k) clearance for the PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT.... Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Microsurgical Technology, Inc. (Redmond, US). The FDA issued a Cleared decision on November 17, 1995 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 Microsurgical Technology, Inc. devices

FDA 510(k) Submission Details - K953959

510(k) Number K953959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date November 17, 1995
Days to Decision 87 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
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 197
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K953959.
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STORZ I/A HANDPIECES
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IOLAB/SITE PERISTALTIC MODULE
K944995 · Chiron Vision Corp. · Oct 1995