Cleared Traditional

K963630 - C.O.L.D.A.

K963630 is an FDA 510(k) clearance for C.O.L.D.A., manufactured by C.O.L.D.A. S.N.C.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K963630 · C.O.L.D.A. S.N.C. · Ophthalmic device
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Oct 1996
Decision
37d
Days
Class 1
Risk

K963630 is an FDA 510(k) clearance for the C.O.L.D.A.. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by C.O.L.D.A. S.N.C. (Valdobbiadene (Tv), IT). The FDA issued a Cleared decision on October 18, 1996 after a review of 37 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 C.O.L.D.A. S.N.C. devices

FDA 510(k) Submission Details - K963630

510(k) Number K963630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1996
Decision Date October 18, 1996
Days to Decision 37 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
73d faster than avg
Panel avg: 110d · This submission: 37d
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 K963630.
VARIOUS SUNGLASSES (NON-PRESCRIPTION)
K963890 · Italian Eyewear, Inc. · Nov 1996
DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS
K963955 · Bert & Joe'S, Inc. · Nov 1996
FLYWAY
K963968 · Look Style, S.R.L. · Nov 1996
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES
K962279 · Jane Fui Optical Co., Ltd. · Aug 1996
RAVEN EYE, INC.- EYE WEAR
K962940 · Raven Eye, Inc. · Aug 1996
LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
K963083 · Piazza Optical Corp. · Aug 1996