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510(k) DEN090008

ERCHONIA ML SCANNER (MLS) by Erchonia Medical — Product Code OLI

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 24, 2010
Date Received
January 5, 2009
Clearance Type
Post-NSE
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

  • K153164 — LunulaLaser (June 3, 2016)
  • K132940 — ERCHONIA ALLAY (April 14, 2014)
  • K130996 — ERCHONIA EMERGE (September 16, 2013)
  • K130922 — ERCHONIA VERJU LASER SYSTEM WITH MASSAGER (May 17, 2013)
  • K130741 — ERCHONIA PL5000 (April 23, 2013)
  • K120257 — MLS, ZERONA-AD (May 14, 2012)
  • 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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  • K252574 — Erchonia CLX (Model # CFL) (December 15, 2025)
  • K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A) (December 1, 2025)
  • K243811 — Erchonia Zerona® VZ8 (January 10, 2025)
  • K232977 — Biophotas Celluma CONTOUR (November 21, 2023)
  • K231474 — Erchonia Violet ZERONA® Z6 OTC (July 21, 2023)
  • K220519 — Erchonia Zerona Z-Bed (March 24, 2022)
  • K213534 — PHantom Trilogy (March 11, 2022)
  • K202955 — Contour Light CL-100 (May 19, 2021)
  • K202361 — UltraSlim Digital, UltraSmooth Digital (December 18, 2020)