Erchonia IOTO_240

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K062792 ↗

FDA Product Code

EGJ

Device Class

Class II

Regulation

21 CFR Part 890.5525

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• LunulaLaser

  Class II

  FDA 510(k) K153164 Active Cleared 3 Jun 2016

• Erchonia Verju Laser System with Massager

  Class II

  FDA 510(k) K130922 Active Cleared 17 May 2013

• Erchonia EMERGE

  Class II

  FDA 510(k) K130996 Active Cleared 16 Sep 2013

• Erchonia Allay

  Class II

  FDA 510(k) K132940 Active Cleared 14 Apr 2014

• Erchonia PL5000

  Class II

  FDA 510(k) K130741 Active Cleared 23 Apr 2013

• Erchonia Ml Scanner (Mls)

  Class II

  FDA De Novo DEN090008 Active Cleared 24 Aug 2010 FDA 510(k)

See all devices from Erchonia Medical, Inc. →