Cleared Traditional

K951757 - DRIVING GLASSES

K951757 is an FDA 510(k) clearance for DRIVING GLASSES, manufactured by Proview Optical Group Corp.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K951757 · Proview Optical Group Corp. · Ophthalmic device
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Oct 1995
Decision
191d
Days
Class 1
Risk

K951757 is an FDA 510(k) clearance for the DRIVING GLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Proview Optical Group Corp. (Santaon, US). The FDA issued a Cleared decision on October 25, 1995 after a review of 191 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.

FDA 510(k) Submission Details - K951757

510(k) Number K951757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date October 25, 1995
Days to Decision 191 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
81d slower than avg
Panel avg: 110d · This submission: 191d
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 K951757.
KMANZ II
K955611 · Gatorz LLC · Jan 1996
HANYANG SUNGLASSES
K955127 · Hanyang Industries, Inc. · Dec 1995
KUO & YANG SUNGLASSES
K955290 · Kuo & Yang Industrial Co., Ltd. · Dec 1995
NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES
K953627 · New Sun Optical Enterprise Co., Ltd. · 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
K951757 · DRIVING GLASSES
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