510(k) K153164

LunulaLaser by Erchonia Medical, Inc. — Product Code PDZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 3, 2016
Date Received: November 2, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Other clearances by Erchonia Medical, Inc.

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)
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)

Other clearances for product code PDZ

K253960 — Medicell Mycosis Laser (MCML24004) (March 9, 2026)
K241116 — Onycho Laser V (July 22, 2024)
K211265 — TFX-LT2000 Therapy Light (November 17, 2022)
K221363 — AF Laser (July 20, 2022)
K190034 — REMY Medical Therapy Laser System (May 15, 2019)
K150138 — Aspen Laser Systems Therapy Laser System (May 8, 2015)
K123014 — LITECURE THERAPY SYSTEM MODEL LTS-1500 (March 29, 2013)
K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (December 12, 2012)
K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)
K120938 — THE PL-1064 LASER SYSTEM (September 24, 2012)