Cleared Traditional

K971462 - SUNGLASSES

K971462 is an FDA 510(k) clearance for SUNGLASSES, manufactured by D.G. Prove Co.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971462 · D.G. Prove Co. · Ophthalmic device
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Jul 1997
Decision
71d
Days
Class 1
Risk

K971462 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 D.G. Prove Co. (Taipei, TW). The FDA issued a Cleared decision on July 1, 1997 after a review of 71 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 D.G. Prove Co. devices

FDA 510(k) Submission Details - K971462

510(k) Number K971462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date July 01, 1997
Days to Decision 71 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
39d faster than avg
Panel avg: 110d · This submission: 71d
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 62
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K971462.
SUNGLASSES
K971385 · Kosway Industries Co., Ltd. · Jul 1997
FOVS, BRILLARTE, ETC...
K972362 · Sunglass City, Inc. · Jul 1997
(BRAND NAME)
K971384 · Long IN Time Ent. Co., Ltd. · Jul 1997
SPECTACLE FRAMES (NON-PRESCRIPTION)
K972246 · Alimar Trading, Inc. · Jun 1997
CEBE
K971644 · Suunto USA · Jun 1997
SUNGLASSES (NON-PRESCRIPTION)
K972014 · Tamfort, Ltd. · Jun 1997