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510(k) K063640

KOWA SL-15 by Kowa Co. , Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2006
Date Received
December 7, 2006
Clearance Type
Special
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 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)
  • K091098 — KOWAGENESIS-DF (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)
  • K062021 — KOWA VX-10I (November 1, 2006)

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)