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510(k) K091098

KOWAGENESIS-DF by Kowa Co. , Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2009
Date Received
April 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Kowa Co. , Ltd.

  • K133755 — KOWA SL-17 (March 11, 2014)
  • K112330 — KOWA VX-20 (February 16, 2012)
  • K101628 — KOWA NONMYD WX (January 26, 2011)
  • K091039 — KOWA, FM-600, MODEL LSS50 (August 7, 2009)
  • K091683 — KOWA VX-10 A (July 2, 2009)
  • K083387 — MODIFICATION TO KOWA NONMYD ALPHA-DIII (January 16, 2009)
  • K082767 — KOWA NONMYD ALPHA-DIII (October 21, 2008)
  • K080681 — KOWA GENESIS-D (April 4, 2008)
  • K063640 — KOWA SL-15 (December 18, 2006)
  • K062021 — KOWA VX-10I (November 1, 2006)

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  • K243664 — Sentinel Camera (December 17, 2024)
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  • K241049 — CANON Fundus Camera CR-10 (CR-10) (May 15, 2024)
  • K231230 — Optina-4C (MHRC-C1N) (December 5, 2023)
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