Cleared Traditional

K954659 - MOONSHADES SUNGLASSES

K954659 is an FDA 510(k) clearance for MOONSHADES SUNGLASSES, manufactured by Blublocker Corp.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K954659 · Blublocker Corp. · Ophthalmic device
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Jan 1996
Decision
93d
Days
Class 1
Risk

K954659 is an FDA 510(k) clearance for the MOONSHADES SUNGLASSES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Blublocker Corp. (Las Vegas, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 93 days - within the typical 510(k) review window.

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.

View all Blublocker Corp. devices

FDA 510(k) Submission Details - K954659

510(k) Number K954659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date January 11, 1996
Days to Decision 93 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
17d faster than avg
Panel avg: 110d · This submission: 93d
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 K954659.
ZONG RONG SUNGLASSES
K955287 · Yuu Yeng Enterprise Co., Ltd. · Jan 1996
ZONG RONG SUNGLASSES
K955441 · Zong Rong Glasses Ltd. Co. · Jan 1996
PLASTIC FRAME, METAL FRAME, OPTICAL
K955695 · Dah Sing Trading Co. · Jan 1996
SUNGLASSES WITH IMPACT RESISTANT LENSES
K955572 · Diamond Mark International Co., Ltd. · Jan 1996
UNISUN
K955539 · Steven Chen · Jan 1996
KMANZ II
K955611 · Gatorz LLC · Jan 1996