Cleared Traditional

K830871 - PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION (FDA 510(k) Clearance)

Class I Ophthalmic device.

K830871 · Phakosystems, Inc. · Ophthalmic device
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Jun 1983
Decision
76d
Days
Class 1
Risk

K830871 is an FDA 510(k) clearance for the PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION. Classified as Clip, Iris Retractor (product code HOC), Class I - General Controls.

Submitted by Phakosystems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phakosystems, Inc. devices

Submission Details

510(k) Number K830871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date June 02, 1983
Days to Decision 76 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 110d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOC Clip, Iris Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.