Cleared Traditional

K861021 - GOTTEX SUNGLASSES

K861021 is an FDA 510(k) clearance for GOTTEX SUNGLASSES, manufactured by Private Eyes Sunglass Corp.. The device is a Class 1 Ophthalmic device with product code HQG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K861021 · Private Eyes Sunglass Corp. · Ophthalmic device
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Jun 1986
Decision
91d
Days
Class 1
Risk

K861021 is an FDA 510(k) clearance for the GOTTEX SUNGLASSES. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Private Eyes Sunglass Corp. (Norwell, US). The FDA issued a Cleared decision on June 17, 1986 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 886.5844 - 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 Private Eyes Sunglass Corp. devices

FDA 510(k) Submission Details - K861021

510(k) Number K861021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date June 17, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

HQG Device Classification - Class 1, General Controls

Product Code HQG Lens, Spectacle, Non-custom (prescription)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
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 - HQG Lens, Spectacle, Non-custom (prescription)

All 8
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K861021.
FORMALENS 2000
K863367 · Vision-Sciences, Inc. · Sep 1986
SPECTACLES LENS
K860955 · Roseburg SA · Mar 1986
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · American Optical Corp. · Sep 1981
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · Chiron Vision Corp. · Dec 1980
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · American Optical Corp. · Oct 1979