Cleared Traditional

K955695 - PLASTIC FRAME, METAL FRAME, OPTICAL

K955695 is an FDA 510(k) clearance for PLASTIC FRAME, manufactured by Dah Sing Trading Co.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K955695 · Dah Sing Trading Co. · Ophthalmic device
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Jan 1996
Decision
47d
Days
Class 1
Risk

K955695 is an FDA 510(k) clearance for the PLASTIC FRAME, METAL FRAME, OPTICAL. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Dah Sing Trading Co. (Tsuen Wan, HK). The FDA issued a Cleared decision on January 29, 1996 after a review of 47 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 Dah Sing Trading Co. devices

FDA 510(k) Submission Details - K955695

510(k) Number K955695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1995
Decision Date January 29, 1996
Days to Decision 47 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
63d faster than avg
Panel avg: 110d · This submission: 47d
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 123
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K955695.
JAMES KOREA OPTICAL FRAMES & SUNGLASSES
K960289 · James Korea Co., Ltd. · Feb 1996
ZONG RONG SUNGLASSES
K955287 · Yuu Yeng Enterprise Co., Ltd. · Jan 1996
ZONG RONG SUNGLASSES
K955441 · Zong Rong Glasses Ltd. Co. · Jan 1996
MOONSHADES SUNGLASSES
K954659 · Blublocker Corp. · Jan 1996
SUNGLASSES WITH IMPACT RESISTANT LENSES
K955572 · Diamond Mark International Co., Ltd. · Jan 1996
UNISUN
K955539 · Steven Chen · Jan 1996