Cleared Traditional

K970816 - GLARE WARE

K970816 is an FDA 510(k) clearance for GLARE WARE, manufactured by Ergovision, Inc.. 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.

K970816 · Ergovision, Inc. · Ophthalmic device
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Jun 1997
Decision
91d
Days
Class 1
Risk

K970816 is an FDA 510(k) clearance for the GLARE WARE. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Ergovision, Inc. (Planview, US). The FDA issued a Cleared decision on June 5, 1997 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.

View all Ergovision, Inc. devices

FDA 510(k) Submission Details - K970816

510(k) Number K970816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1997
Decision Date June 05, 1997
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 62
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K970816.
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087 · W.J. Byrnes & Co. of Los Angeles, Inc. · Jun 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707 · Niko Sunglasses Corp. · Jun 1997
OPTIM-EYES 450
K971875 · Taylor/Fox Enterprises, LLC · Jun 1997
DUQIAO
K971551 · Duqiao Glasses (Group) Co. , Ltd. · Jun 1997
PATHFINDER SUNGLASSES
K971495 · Coil · May 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699 · Yeong Jiuh Corp. · May 1997