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510(k) K201325

Optomed Smartscope M5 with Optomed Smartscope FA by Optomed Oyj — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
May 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Oyj

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  • K132186 — OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 (December 18, 2013)
  • K110986 — OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 (May 16, 2011)
  • 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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