LunulaLaser

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K153164 ↗

FDA Product Code

PDZ

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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 IOTO_240

  Class II

  FDA 510(k) K062792 Active Cleared 1 Mar 2007

• 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. →