Home / 510(k) Clearances / K192045

510(k) K192045

Ophthalmic Yag Laser System YC-200 by Nidek Co., Ltd. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2019
Date Received
July 31, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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)
  • 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)
  • K151706 — Specular Microscope CEM- 530 (March 17, 2016)

Other clearances for product code HQF

  • K251507 — INTEGRE LIO (February 6, 2026)
  • K251772 — Navilas Laser System 577sl (156691) (October 29, 2025)
  • K243014 — EyeQ nanoECP (June 18, 2025)
  • K240615 — Leos Laser and Endoscopy System (April 3, 2025)
  • K242397 — LYNX Photocoagulator (October 25, 2024)
  • K233911 — VISULAS combi (September 6, 2024)
  • K232417 — MR Q; MR Q SUPINE; MR Q SLT (January 25, 2024)
  • K230722 — Eagle device (December 8, 2023)
  • K232051 — VISULAS green (October 24, 2023)
  • K230350 — VISULAS yag (September 22, 2023)