Cleared Traditional

K973016 - NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS

K973016 is an FDA 510(k) clearance for NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANA..., manufactured by Optimaxx Intl.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K973016 · Optimaxx Intl. · Ophthalmic device
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Sep 1997
Decision
35d
Days
Class 1
Risk

K973016 is an FDA 510(k) clearance for the NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Optimaxx Intl. (Rockleigh, US). The FDA issued a Cleared decision on September 17, 1997 after a review of 35 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 Optimaxx Intl. devices

FDA 510(k) Submission Details - K973016

510(k) Number K973016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date September 17, 1997
Days to Decision 35 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
75d faster than avg
Panel avg: 110d · This submission: 35d
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 62
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K973016.
SUNGLASSES (NON-PRESCRIPTION)
K973407 · Pacific Optical Co. , Ltd. · Sep 1997
SUNGLASSES
K973490 · Tong Yang Optical Co. · Sep 1997
SUNGLASSES
K972850 · Indoptica, S.A. · Sep 1997
RUFF WORK EYEGEAR
K972717 · Ruff House, Inc. · Aug 1997
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · Lbi U.S.A. · Jul 1997
D'ARC EYE CARE SUNGLASSES
K972490 · M & R Dist. · Jul 1997