Cleared Traditional

K843277 - IOCARE PHACOEMULSIFICATION PACK

K843277 is an FDA 510(k) clearance for IOCARE PHACOEMULSIFICATION PACK, manufactured by Chiron Vision Corp.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K843277 · Chiron Vision Corp. · Ophthalmic device
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Nov 1984
Decision
99d
Days
Class 2
Risk

K843277 is an FDA 510(k) clearance for the IOCARE PHACOEMULSIFICATION PACK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 99 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 Chiron Vision Corp. devices

FDA 510(k) Submission Details - K843277

510(k) Number K843277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date November 27, 1984
Days to Decision 99 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
11d faster than avg
Panel avg: 110d · This submission: 99d
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 195
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K843277.
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
IOCARE ULTRASONIC TITANIUM TIPS
K843278 · Chiron Vision Corp. · Nov 1984
MENDEZ U/S CYSTOTOME
K843386 · CooperVision, Inc. · Nov 1984
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · Chiron Vision Corp. · Aug 1984