Cleared Traditional

K960818 - SUNGLASSES

K960818 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Visard Srl. 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.

K960818 · Visard Srl · Ophthalmic device
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May 1996
Decision
93d
Days
Class 1
Risk

K960818 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 Visard Srl (Belluno, IT). The FDA issued a Cleared decision on May 31, 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 Visard Srl devices

FDA 510(k) Submission Details - K960818

510(k) Number K960818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1996
Decision Date May 31, 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 K960818.
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
K962107 · Leonachi, Inc. · Jun 1996
NON-PRESCRIPTION SUNGLASSES
K961990 · Rokko Stars Co., Ltd. · Jun 1996
MISTRAL SUNGLASSES
K960668 · Mistral Optical · May 1996
SUNGLASSES
K960953 · Galilee Optics · May 1996
SUNGLASSES
K961146 · Erica Optical Co. · May 1996
SPECTACLE FRAMES/SUNGLASSES
K954419 · Ami Fashion · May 1996