Cleared Traditional

K842945 - COOPERVISION SYSTEM VI

K842945 is an FDA 510(k) clearance for COOPERVISION SYSTEM VI, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K842945 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
139d
Days
Class 2
Risk

K842945 is an FDA 510(k) clearance for the COOPERVISION SYSTEM VI. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 139 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K842945

510(k) Number K842945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1984
Decision Date December 11, 1984
Days to Decision 139 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 110d · This submission: 139d
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 193
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K842945.
PHACO-BAC STOP KIT
K850900 · Staar Surgical Co. · Mar 1985
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K843487 · Visitec Co. · Mar 1985
SITE ULTRASONIC EMULSIFICATION MODULE OP
K844666 · Chiron Vision Corp. · Dec 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K844150 · American Medical Optics · Dec 1984
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K842979 · CooperVision, Inc. · Nov 1984
IOCARE IRRIGATION/ASPIRATION PACK
K843275 · Chiron Vision Corp. · Nov 1984