ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES

K962279 · Jane Fui Optical Co., Ltd. · HQY · Aug 26, 1996 · Ophthalmic

Device Facts

Record IDK962279
Device NameACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES
ApplicantJane Fui Optical Co., Ltd.
Product CodeHQY · Ophthalmic
Decision DateAug 26, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 886.5850
Device ClassClass 1

Regulatory Classification

Identification

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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