Cleared Traditional

K833784 - DISPOSABLE I/A HANDPIECE

K833784 is an FDA 510(k) clearance for DISPOSABLE I/A HANDPIECE, 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 116-day FDA review.

K833784 · CooperVision, Inc. · Ophthalmic device
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Feb 1984
Decision
116d
Days
Class 2
Risk

K833784 is an FDA 510(k) clearance for the DISPOSABLE I/A HANDPIECE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on February 21, 1984 after a review of 116 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 - K833784

510(k) Number K833784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1983
Decision Date February 21, 1984
Days to Decision 116 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
6d slower than avg
Panel avg: 110d · This submission: 116d
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 K833784.
I/A PLUS PAK SURGICAL SYSTEM
K833961 · Ipax, Inc. · Mar 1984
KPE PLUS-PAK SURGICAL SYSTEM
K833962 · Ipax, Inc. · Mar 1984
DISPOS. I/A & IRRIGATION HANDPIECES
K833783 · CooperVision, Inc. · Mar 1984
IRRIGATION ASPIRATION KIT
K833405 · American Medical Optics · Jan 1984
STORZ EXTRA
K833064 · Storz Instrument Co. · Jan 1984
EPSILON ULTRASONIC TIP
K831836 · CooperVision, Inc. · Jun 1983