Cleared Traditional

XCEL 255 SLIT LAMP

K063750 · Reichert, Inc. · Ophthalmic
Dec 2006
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K063750 is an FDA 510(k) clearance for the XCEL 255 SLIT LAMP, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on December 20, 2006, 1 days after receiving the submission on December 19, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K063750 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2006
Decision Date December 20, 2006
Days to Decision 1 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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