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510(k) K954782

KOWA PORTABLE SLIT LAMP SL-14 & SL-14B by Kowa Optimed, Inc. — Product Code HJO

K954782 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "KOWA PORTABLE SLIT LAMP SL-14 & SL-14B". The FDA issued a decision of Substantially Equivalent on November 24, 1995. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1995
Date Received
October 17, 1995
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)
  • K954781 — KOWA GENESIS HAND-HELD FUNDUS CAMERA (December 1, 1995)
  • K954780 — KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (December 1, 1995)
  • K913852 — LASER FLARE METER (February 7, 1992)
  • K880920 — LASER FLARE CELL METER FC-1000 (September 27, 1988)
  • K881219 — AUTOMATIC PERIMETER, AP-340 (May 3, 1988)

Other clearances for product code HJO

  • K253834 — VISUREF 600 (March 18, 2026)
  • 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)

FDA data resources