Cleared Traditional

K955789 - ALCON SERIES 20000 LEGACY MACKOOL SYSTEM

K955789 is the FDA 510(k) clearance for ALCON SERIES 20000 LEGACY MACKOOL SYSTEM by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955789 · Alcon Laboratories · Ophthalmic device
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Mar 1996
Decision
90d
Days
Class 2
Risk

K955789 is an FDA 510(k) clearance for the ALCON SERIES 20000 LEGACY MACKOOL SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 90 days - within the typical 510(k) review window.

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 Alcon Laboratories devices

Submission Details

510(k) Number K955789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date March 21, 1996
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 75
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K955789.
STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
K961820 · Storz Instrument Co. · Jul 1996
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
K961310 · Storz Instrument Co. · Jun 1996
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
K955901 · Storz Instrument Co. · Mar 1996
STORZ I/A HANDPIECES
K951463 · Storz Instrument Co. · Oct 1995
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K952213 · Alcon Laboratories · Aug 1995
STORZ DP4101 BASIC I/A PACK
K953078 · Storz Instrument Co. · Aug 1995