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510(k) K003299

OPD-SCAN, MODELS ARK-10000 AND ARK-9000 by Nidek Co., Ltd. — Product Code HLQ

K003299 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "OPD-SCAN, MODELS ARK-10000 AND ARK-9000". The FDA issued a decision of SESU on March 9, 2001. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Nidek Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
March 9, 2001
Date Received
October 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
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 HLQ

  • K973756 — EYE SYS VISTA (November 13, 1997)
  • K964290 — EYECHEK (January 9, 1997)
  • K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (January 31, 1995)
  • K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (December 7, 1994)
  • K944616 — KERATRON CORNEAL TOPOGRAPHER (November 22, 1994)
  • K940647 — ORBSCAN(TM) KERATOMETER (July 6, 1994)
  • K933556 — EH-270 CORNEAL TOPOGRAPHER (November 2, 1993)
  • K923435 — CORNEAL TOPOGRAPHY SYSTEM (February 16, 1993)
  • K922253 — KERATOREF L60 (June 19, 1992)
  • K912740 — ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (December 30, 1991)

FDA data resources