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510(k) K110986

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 by Optomed OY — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2011
Date Received
April 8, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Optomed OY

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  • K180378 — Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (April 5, 2018)
  • K163021 — HAAG-STREIT FUNDUS MODULE 300 (April 11, 2017)
  • K132186 — OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 (December 18, 2013)
  • K092056 — OPTOMED SMARTSCOPE, MODEL M3-1 EY1 (October 1, 2009)
  • K990417 — DERMACOOL (April 14, 1999)
  • K923531 — OPTOSCALPEL I LASER SYSTEM (November 12, 1993)

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