Cleared Traditional

SLIT LAMP

K073190 · Huvitz Co., Ltd. · Ophthalmic
Jan 2008
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K073190 is an FDA 510(k) clearance for the SLIT LAMP, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Huvitz Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on January 11, 2008, 59 days after receiving the submission on November 13, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K073190 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2007
Decision Date January 11, 2008
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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