Cleared Traditional

K942951 - ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS

K942951 is an FDA 510(k) clearance for ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS, manufactured by The Orvis Co., Inc.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K942951 · The Orvis Co., Inc. · Ophthalmic device
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Aug 1994
Decision
40d
Days
Class 1
Risk

K942951 is an FDA 510(k) clearance for the ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by The Orvis Co., Inc. (Manchester, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 40 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 The Orvis Co., Inc. devices

FDA 510(k) Submission Details - K942951

510(k) Number K942951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date August 02, 1994
Days to Decision 40 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 110d · This submission: 40d
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 124
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K942951.
SUNGLASSES WITH IMPACT RESISTANT LENSES
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KMANZ II
K955611 · Gatorz LLC · Jan 1996
PHOTOCHROMIC LENS
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CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · Roseburg SA · Mar 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989