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510(k) K253960

Medicell Mycosis Laser (MCML24004) by Medicell Healthcare Co.,LTD — Product Code PDZ

K253960 is an FDA 510(k) premarket notification submitted by Medicell Healthcare Co.,LTD for the device "Medicell Mycosis Laser (MCML24004)". The FDA issued a decision of Substantially Equivalent on March 9, 2026. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2026
Date Received
December 10, 2025
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 for product code PDZ

  • 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)
  • K153164 — LunulaLaser (June 3, 2016)
  • 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