Cleared Traditional

K951815 - SUNGLASSES

K951815 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Fung Won Optical Mfg. Co.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K951815 · Fung Won Optical Mfg. Co. · Ophthalmic device
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Jun 1995
Decision
91d
Days
Class 1
Risk

K951815 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 Fung Won Optical Mfg. Co. (Dae Gu, KR). The FDA issued a Cleared decision on June 26, 1995 after a review of 91 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.

FDA 510(k) Submission Details - K951815

510(k) Number K951815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date June 26, 1995
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
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 K951815.
SUNGLASSES
K951979 · Heyro Optical Manufactory · Jul 1995
SUNGLASSES
K952890 · Isohyper · Jul 1995
METAL FRAM WITH POLYCARBONATE LENS
K953002 · Nakanishi Optical Products Corp. · Jul 1995
FAIRY WORLD INC
K951992 · Fairy World, Inc. · Jun 1995
SPECTACLE SUN GLASSES
K940324 · Occhiali, International Eyewear · May 1995
SUNBLOCKER SUNGLASSES
K950807 · Blublocker Corp. · May 1995
K951815 · SUNGLASSES
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