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510(k) K092056

OPTOMED SMARTSCOPE, MODEL M3-1 EY1 by Optomed OY — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2009
Date Received
July 7, 2009
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

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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)
  • K990417 — DERMACOOL (April 14, 1999)
  • K923531 — OPTOSCALPEL I LASER SYSTEM (November 12, 1993)

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