Cleared Traditional

MULTIPLE LENS, SPECTACLES CUSTOM (K842189) - FDA 510(k) Clearance

Class I Ophthalmic device.

K842189 · Hanmy Optical Industrial Co. · Ophthalmic device
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Dec 1984
Decision
190d
Days
Class 1
Risk

K842189 is an FDA 510(k) clearance for the MULTIPLE LENS, SPECTACLES CUSTOM. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Hanmy Optical Industrial Co. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 190 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - 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 Hanmy Optical Industrial Co. devices

Submission Details

510(k) Number K842189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date December 11, 1984
Days to Decision 190 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 110d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQG Lens, Spectacle, Non-custom (prescription)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
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.