Cleared Traditional

K833465 - DISPOSABLE FIBER OPTIC ILLUMINATOR

K833465 is an FDA 510(k) clearance for DISPOSABLE FIBER OPTIC ILLUMINATOR, 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 162-day FDA review.

K833465 · CooperVision, Inc. · Ophthalmic device
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Mar 1984
Decision
162d
Days
Class 2
Risk

K833465 is an FDA 510(k) clearance for the DISPOSABLE FIBER OPTIC ILLUMINATOR. 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 15, 1984 after a review of 162 days - an extended review cycle.

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 - K833465

510(k) Number K833465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date March 15, 1984
Days to Decision 162 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
52d slower than avg
Panel avg: 110d · This submission: 162d
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 K833465.
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K840965 · Chiron Vision Corp. · May 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · Chiron Vision Corp. · Apr 1984
MICRO VIT FRAGMENTATION SYSTEM
K834537 · Medical Instrument Development Laboratories, Inc. · Mar 1984
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