Cleared Traditional

K833642 - PHAKO SYSTEMS VIA 2000

K833642 is an FDA 510(k) clearance for PHAKO SYSTEMS VIA 2000, manufactured by Pharosystems, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K833642 · Pharosystems, Inc. · Ophthalmic device
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Mar 1984
Decision
140d
Days
Class 2
Risk

K833642 is an FDA 510(k) clearance for the PHAKO SYSTEMS VIA 2000. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Pharosystems, Inc. (Walker, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 140 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 Pharosystems, Inc. devices

FDA 510(k) Submission Details - K833642

510(k) Number K833642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date March 05, 1984
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 110d · This submission: 140d
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 198
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K833642.
DISPOSABLE FIBER OPTIC ILLUMINATOR
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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
DISPOSABLE I/A HANDPIECE
K833784 · CooperVision, Inc. · Feb 1984
IRRIGATION ASPIRATION KIT
K833405 · American Medical Optics · Jan 1984