510(k) K121622

NIDEK RS-3000 by Nidek Co., Ltd. — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 14, 2013
Date Received: June 1, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomography, Optical Coherence
Device Class: Class II
Regulation Number: 886.1570
Review Panel: OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Nidek Co., Ltd.

K221320 — Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software (March 30, 2023)
K203130 — Ophthalmic Yag Laser System YC-200 (December 7, 2020)
K192045 — Ophthalmic Yag Laser System YC-200 (November 15, 2019)
K190198 — Microperimeter MP-3, Microperimeter MP-3 Type S (April 1, 2019)
K181345 — Image Filing Software NAVIS-EX (July 19, 2018)
K173980 — Specular Microscope CEM-530 (March 14, 2018)
K170302 — YELLOW LASER PHOTOCOAGULATOR YLC-500 (June 23, 2017)
K163564 — SLIT LAMP SL-2000 (May 19, 2017)
K152729 — MICROPERIMETER MP-3 (June 6, 2016)
K152603 — Green Laser Photocoagulator GYC-500 (May 2, 2016)

Other clearances for product code OBO

K252633 — UNITY DX (UDX) (December 23, 2025)
K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
K240924 — Anterion (December 13, 2024)
K241163 — SPECTRALIS with Flex Module (October 11, 2024)
K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
K233933 — CIRRUS HD-OCT Model 6000 (May 17, 2024)
K233602 — P200TE (A10700) (May 9, 2024)
K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)