Cleared Traditional

OPTICAL BIOMETER AL-SCAN

K133132 · Nidek Co., Ltd. · Ophthalmic
Jun 2014
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K133132 is an FDA 510(k) clearance for the OPTICAL BIOMETER AL-SCAN, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Nidek Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on June 11, 2014, 254 days after receiving the submission on September 30, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K133132 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2013
Decision Date June 11, 2014
Days to Decision 254 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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