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510(k) K880920

LASER FLARE CELL METER FC-1000 by Kowa Optimed, Inc. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1988
Date Received
March 4, 1988
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 Kowa Optimed, Inc.

  • K013805 — KOWA AUTOMATED TONOMETER KT-500 (October 11, 2002)
  • K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125 (June 17, 1996)
  • K960924 — KOWA HAND-HELD APPLANATION TONOMETER HA-1 (June 4, 1996)
  • K955442 — KOWA SC-1200 PHOTO SLIT LAMP SYSTEM (January 3, 1996)
  • K954780 — KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (December 1, 1995)
  • K954781 — KOWA GENESIS HAND-HELD FUNDUS CAMERA (December 1, 1995)
  • K954782 — KOWA PORTABLE SLIT LAMP SL-14 & SL-14B (November 24, 1995)
  • K913852 — LASER FLARE METER (February 7, 1992)
  • K881219 — AUTOMATIC PERIMETER, AP-340 (May 3, 1988)

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  • 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)