# Nidek, Inc.

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 100 (1983–2023): 98 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Nidek, Inc. (78); Nidek Co., Ltd. (21); Nidek Incorporated (1)
- Product codes: GEX (23), HQF (13), HKO (8), IYO (7), HQB (5), HKI (5), HLQ (4), HQC (4), HQE (4), HLI (3), OBO (3), NQE (3)
- 510(k) review time since 2016: median 143 days, against 146 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 70 (26 its own); citations of its devices by later devices: 66 (26 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carl Zeiss Meditec, AG: 3 (https://510kreport.com/company/carl-zeiss-meditec)
- Konan Medical, Inc.: 3 (https://510kreport.com/company/konan-medical)
- Optovue, Inc.: 3 (https://510kreport.com/company/optovue)
- Iriderm Div.: 2 (https://510kreport.com/company/iriderm-div)
- Nidek Technologies Srl: 2 (https://510kreport.com/company/nidek-technologies)
- Sharplan Lasers, Inc.: 1 (https://510kreport.com/company/sharplan-lasers)
- Candela Corp.: 1 (https://510kreport.com/company/candela)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)

## Firms that cite its devices most
- Lumenis, Inc.: 5 (https://510kreport.com/company/lumenis)
- Nidek Technologies Srl: 3 (https://510kreport.com/company/nidek-technologies)
- Quantel Medical: 3 (https://510kreport.com/company/quantel-medical)
- Oasis Medical, Inc.: 2 (https://510kreport.com/company/oasis-medical)
- Carl Zeiss Meditec, AG: 2 (https://510kreport.com/company/carl-zeiss-meditec)
- Iridex Corp: 2 (https://510kreport.com/company/iridex)
- Oculus Optikgerate GmbH: 2 (https://510kreport.com/company/oculus-optikgerate)
- Kowa Co., Ltd.: 2 (https://510kreport.com/company/kowa)

## Its most-cited devices
- K013694: Nidek Advanced Vision Information System (Navis) (2002), cited by 7
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000 (2002), cited by 5
- K032085: Green Laser Photocoagulator Model Gyc-1000 (2003), cited by 4
- K013760: DC-3300 Laser Diode Photocoagulator (2002), cited by 4
- K042785: Multi Color Laser Photocoagulator, Model MC-300 (2004), cited by 3
- K110228: Nidek Multicolor Laser Photocoagulator (2011), cited by 3

## Recent decisions
- K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (Mar 30, 2023)
- K203130: Ophthalmic Yag Laser System YC-200 (Dec 7, 2020)
- K192045: Ophthalmic Yag Laser System YC-200 (Nov 15, 2019)
- K190198: Microperimeter MP-3, Microperimeter MP-3 Type S (Apr 1, 2019)
- K181345: Image Filing Software NAVIS-EX (Jul 19, 2018)
- K173980: Specular Microscope CEM-530 (Mar 14, 2018)
- K170302: Yellow Laser Photocoagulator Ylc-500 (Jun 23, 2017)
- K163564: Slit Lamp SL-2000 (May 19, 2017)

Source page: https://510kreport.com/company/nidek