Cleared Traditional

K851674 - PHAKOSYSTEMS MODEL CES 4100

K851674 is an FDA 510(k) clearance for PHAKOSYSTEMS MODEL CES 4100, manufactured by Phakosystems, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K851674 · Phakosystems, Inc. · Ophthalmic device
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Aug 1985
Decision
104d
Days
Class 2
Risk

K851674 is an FDA 510(k) clearance for the PHAKOSYSTEMS MODEL CES 4100. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Phakosystems, Inc. (Canada, CA). The FDA issued a Cleared decision on August 5, 1985 after a review of 104 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 Phakosystems, Inc. devices

FDA 510(k) Submission Details - K851674

510(k) Number K851674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date August 05, 1985
Days to Decision 104 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 110d · This submission: 104d
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 198
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K851674.
O.M.S. ULTRA-PHACO
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PHACO-BAC STOP FILTER KIT
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COOPER VISION SYSTEM VI U/S MODULE
K853070 · CooperVision, Inc. · Aug 1985
IOCARE CONVERTER KIT
K843276 · Chiron Vision Corp. · May 1985
KCP PAK CONVENIENCE PACK
K850148 · CooperVision, Inc. · Apr 1985
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
K850149 · CooperVision, Inc. · Apr 1985