Cleared Traditional

ARCTIC PREMIER SERIES

K944700 · Sungold Eyewear, Inc. · Ophthalmic

Dec 1994

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K944700 is an FDA 510(k) clearance for the ARCTIC PREMIER SERIES, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by Sungold Eyewear, Inc. (Kent, US). The FDA issued a Cleared decision on December 22, 1994, 90 days after receiving the submission on September 23, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K944700 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 1994
Decision Date	December 22, 1994
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

Device Classification

Product Code	HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 886.4750