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510(k) K120257

MLS, ZERONA-AD by Erchonia Medical, Inc. — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2012
Date Received
January 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fat Reducing Low Level Laser
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Non-invasive reduction in fat layer for body contouring

Other clearances by Erchonia Medical, Inc.

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  • K130922 — ERCHONIA VERJU LASER SYSTEM WITH MASSAGER (May 17, 2013)
  • K130741 — ERCHONIA PL5000 (April 23, 2013)
  • DEN090008 — ERCHONIA ML SCANNER (MLS) (August 24, 2010)
  • K072206 — ERCHONIA EML LASER (April 24, 2008)
  • K062792 — ERCHONIA IOTO_240 (March 1, 2007)
  • K050672 — ERCHONIA EVRL LASER (May 2, 2005)
  • K041139 — ERCHONIA EML LASER (September 30, 2004)

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