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510(k) K093639

SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 by Huvitz Co., Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2009
Date Received
November 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Huvitz Co., Ltd.

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  • K202097 — Fundus Camera (February 2, 2021)
  • K191615 — Huvitz Imaging System (July 18, 2019)
  • K161829 — Huvitz Imaging System (April 6, 2017)
  • K073190 — SLIT LAMP (January 11, 2008)

Other clearances for product code HJO

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  • 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)