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510(k) K153164

LunulaLaser by Erchonia Medical, Inc. — Product Code PDZ

K153164 is an FDA 510(k) premarket notification submitted by Erchonia Medical, Inc. for the device "LunulaLaser". The FDA issued a decision of Substantially Equivalent on June 3, 2016. The device falls under product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis), a Class II device regulated under 21 CFR 878.4810. Erchonia Medical, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources