Cleared Traditional

NIL (K943613) - FDA 510(k) Clearance

Class I Ophthalmic device.

K943613 · Sing Wah International Enterprises , Ltd. · Ophthalmic device
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Sep 1994
Decision
56d
Days
Class 1
Risk

K943613 is an FDA 510(k) clearance for the NIL. Classified as Spectacle, Magnifying (product code HOI), Class I - General Controls.

Submitted by Sing Wah International Enterprises , Ltd. (Connaught, HK). The FDA issued a Cleared decision on September 21, 1994 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5840 - 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 Sing Wah International Enterprises , Ltd. devices

Submission Details

510(k) Number K943613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1994
Decision Date September 21, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOI Spectacle, Magnifying
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5840
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.