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510(k) K003299

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

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

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  • K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (December 7, 1994)
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  • 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)