Home / 510(k) Clearances / K133132

510(k) K133132

OPTICAL BIOMETER AL-SCAN by Nidek Co., Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2014
Date Received
September 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
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)
  • 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 HJO

  • K231760 — HP-OCT (HP-OCT) (March 8, 2024)
  • K222372 — Kowa SL-19 (November 21, 2022)
  • K193188 — MiiS Horus Eye Anterior Camera (January 14, 2020)
  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)
  • K173771 — IOLMaster 700 (August 24, 2018)
  • K171877 — SLM-1ER, SLM-2ER, SLM-3ER (December 21, 2017)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
  • K162778 — Portable Slit Lamp Microscope (July 21, 2017)
  • K162684 — SL 220 (May 31, 2017)
  • K163564 — SLIT LAMP SL-2000 (May 19, 2017)