Cleared Traditional

SUNGLASSES (K940561) - FDA 510(k) Clearance

Class I Ophthalmic device.

K940561 · Hibiscus Ind. Co. , Ltd. · Ophthalmic device
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Aug 1994
Decision
178d
Days
Class 1
Risk

K940561 is an FDA 510(k) clearance for the SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Hibiscus Ind. Co. , Ltd. (Taipei Taiwan R.O.C., TW). The FDA issued a Cleared decision on August 4, 1994 after a review of 178 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5850 - 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 Hibiscus Ind. Co. , Ltd. devices

Submission Details

510(k) Number K940561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date August 04, 1994
Days to Decision 178 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
68d slower than avg
Panel avg: 110d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
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.