Cleared Traditional

K955789 - ALCON SERIES 20000 LEGACY MACKOOL SYSTEM

K955789 is an FDA 510(k) clearance for ALCON SERIES 20000 LEGACY MACKOOL SYSTEM, manufactured by Alcon Laboratories. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K955789

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.

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 191
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K955789.
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K954746 · U.S. Iol, Inc. · Jan 1996
SURGIN GENISIS HANDPIECE
K954238 · Surgin Surgical Instrumentation, Inc. · Dec 1995