Cleared Traditional

NIDEK RS-3000

K121622 · Nidek Co., Ltd. · Ophthalmic

Mar 2013

Decision

286d

Days

Class 2

Risk

About This 510(k) Submission

K121622 is an FDA 510(k) clearance for the NIDEK RS-3000, 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 March 14, 2013, 286 days after receiving the submission on June 1, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K121622 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2012
Decision Date	March 14, 2013
Days to Decision	286 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.