Cleared Traditional

K953808 - CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES

K953808 is an FDA 510(k) clearance for CHENG CHEN HSING NON-PRESCRIPTION SUNGL..., manufactured by Cheng Chen Hsing Enterp. & Fact. Co. , Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K953808 · Cheng Chen Hsing Enterp. & Fact. Co. , Ltd. · Ophthalmic device
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Oct 1995
Decision
79d
Days
Class 1
Risk

K953808 is an FDA 510(k) clearance for the CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Cheng Chen Hsing Enterp. & Fact. Co. , Ltd. (Tainan Hsien, TW). The FDA issued a Cleared decision on October 25, 1995 after a review of 79 days - a notably fast clearance 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: 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 Cheng Chen Hsing Enterp. & Fact. Co. , Ltd. devices

FDA 510(k) Submission Details - K953808

510(k) Number K953808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date October 25, 1995
Days to Decision 79 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
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HQY Sunglasses (non-prescription Including Photosensitive)

All 124
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K953808.
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PHOTOCHROMIC LENS
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ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989