Cleared Traditional

RS-3000 ADVANCE

K132323 · Nidek Co., Ltd. · Ophthalmic

Feb 2014

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K132323 is an FDA 510(k) clearance for the RS-3000 ADVANCE, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Nidek Co., Ltd. (Wadsworth, US). The FDA issued a Cleared decision on February 19, 2014, 209 days after receiving the submission on July 25, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K132323 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2013
Decision Date	February 19, 2014
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.