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510(k) K062792

ERCHONIA IOTO_240 by Erchonia Medical, Inc. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2007
Date Received
September 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

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  • K050672 — ERCHONIA EVRL LASER (May 2, 2005)
  • K041139 — ERCHONIA EML LASER (September 30, 2004)

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