Cleared Traditional

SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500

K093639 · Huvitz Co., Ltd. · Ophthalmic

Dec 2009

Decision

Days

Class 2

Risk

About This 510(k) Submission

K093639 is an FDA 510(k) clearance for the SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Huvitz Co., Ltd. (Tempe, US). The FDA issued a Cleared decision on December 3, 2009, 9 days after receiving the submission on November 24, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K093639 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2009
Decision Date	December 03, 2009
Days to Decision	9 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF