Cleared Traditional

K953627 - NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES

K953627 is an FDA 510(k) clearance for NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES, manufactured by New Sun Optical Enterprise Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K953627 · New Sun Optical Enterprise Co., Ltd. · Ophthalmic device
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Oct 1995
Decision
86d
Days
Class 1
Risk

K953627 is an FDA 510(k) clearance for the NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by New Sun Optical Enterprise Co., Ltd. (Taiwan Hsien, TW). The FDA issued a Cleared decision on October 25, 1995 after a review of 86 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.

FDA 510(k) Submission Details - K953627

510(k) Number K953627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date October 25, 1995
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
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 645
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K953627.
HANYANG SUNGLASSES
K955127 · Hanyang Industries, Inc. · Dec 1995
KUO & YANG SUNGLASSES
K955290 · Kuo & Yang Industrial Co., Ltd. · Dec 1995
DRIVING GLASSES
K951757 · Proview Optical Group Corp. · Oct 1995
AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES
K953744 · Amita Corp. · Oct 1995
CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES
K953808 · Cheng Chen Hsing Enterp. & Fact. Co. , Ltd. · Oct 1995
SINCLAIR NON-PRESCRIPTION SUNGLASSES
K954393 · Sinclair Corp. · Oct 1995
K953627 · NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES
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