Cleared Traditional

K843487 - VISITEC OPHTHALMIC FLUID DISTRIB- SET

K843487 is an FDA 510(k) clearance for VISITEC OPHTHALMIC FLUID DISTRIB- SET, manufactured by Visitec Co.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K843487 · Visitec Co. · Ophthalmic device
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Mar 1985
Decision
188d
Days
Class 2
Risk

K843487 is an FDA 510(k) clearance for the VISITEC OPHTHALMIC FLUID DISTRIB- SET. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on March 13, 1985 after a review of 188 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 Visitec Co. devices

FDA 510(k) Submission Details - K843487

510(k) Number K843487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date March 13, 1985
Days to Decision 188 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
78d slower than avg
Panel avg: 110d · This submission: 188d
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 201
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K843487.
INFUSION SLEEVE - OPHTHALMIC
K851009 · Medical Instrument Development Laboratories, Inc. · Apr 1985
I/A BAC STOP KIT
K850899 · Staar Surgical Co. · Mar 1985
PHACO-BAC STOP KIT
K850900 · Staar Surgical Co. · Mar 1985
SITE ULTRASONIC EMULSIFICATION MODULE OP
K844666 · Chiron Vision Corp. · Dec 1984
COOPERVISION SYSTEM VI
K842945 · CooperVision, Inc. · Dec 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K844150 · American Medical Optics · Dec 1984