Cleared Traditional

K951979 - SUNGLASSES

K951979 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Heyro Optical Manufactory. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K951979 · Heyro Optical Manufactory · Ophthalmic device
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Jul 1995
Decision
81d
Days
Class 1
Risk

K951979 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 Heyro Optical Manufactory (Chicago, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 81 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 - K951979

510(k) Number K951979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1995
Decision Date July 17, 1995
Days to Decision 81 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
29d faster than avg
Panel avg: 110d · This submission: 81d
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 K951979.
NYX GOLF VISION SYSTEM
K953245 · Nyx Golf, Inc. · Jul 1995
SUNGLASSES
K953260 · Eye Deals · Jul 1995
FREDEIC BEAUSOCEIL
K951551 · Pascal Mathieux · Jul 1995
SUNGLASSES
K952890 · Isohyper · Jul 1995
METAL FRAM WITH POLYCARBONATE LENS
K953002 · Nakanishi Optical Products Corp. · Jul 1995
SUNGLASSES
K951815 · Fung Won Optical Mfg. Co. · Jun 1995
K951979 · SUNGLASSES
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