Cleared Traditional

K833783 - DISPOS. I/A & IRRIGATION HANDPIECES

K833783 is the FDA 510(k) clearance for DISPOS. I/A & IRRIGATION HANDPIECES by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K833783 · CooperVision, Inc. · Ophthalmic device

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Mar 1984

Decision

129d

Days

Class 2

Risk

K833783 is an FDA 510(k) clearance for the DISPOS. I/A & IRRIGATION HANDPIECES. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on March 5, 1984 after a review of 129 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

Submission Details

510(k) Number	K833783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 28, 1983
Decision Date	March 05, 1984
Days to Decision	129 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

19d slower than avg

Panel avg: 110d · This submission: 129d

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 80

Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K833783.

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA

K842979 · CooperVision, Inc. · Nov 1984

MENDEZ U/S CYSTOTOME

K843386 · CooperVision, Inc. · Nov 1984

DISPOSABLE FIBER OPTIC ILLUMINATOR

K833465 · CooperVision, Inc. · Mar 1984

DISPOSABLE I/A HANDPIECE

K833784 · CooperVision, Inc. · Feb 1984

STORZ EXTRA

K833064 · Storz Instrument Co. · Jan 1984

EPSILON ULTRASONIC TIP

K831836 · CooperVision, Inc. · Jun 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833783

CooperVision, Inc.

Southampton · GB

Regulatory profile

97 submissions 94 cleared

97% clearance rate · Active in Ophthalmic

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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