Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medicell Mycosis Laser (MCML24004)

K-Number: K253960 · 2026-03-09

ApplicantMedicell Healthcare Co.,LTD
Decision Date2026-03-09
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medicell Mycosis Laser (MCML24004) is a medical device manufactured by Medicell Healthcare Co.,LTD. It received FDA 510(k) clearance on 2026-03-09 under approval number K253960. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medicell Mycosis Laser (MCML24004)?

Medicell Mycosis Laser (MCML24004) is a medical device that received FDA 510(k) clearance on 2026-03-09. It is manufactured by Medicell Healthcare Co.,LTD. The 510(k) number is K253960.

When was Medicell Mycosis Laser (MCML24004) approved by the FDA?

Medicell Mycosis Laser (MCML24004) received FDA 510(k) clearance on 2026-03-09, under approval number K253960.

What company makes Medicell Mycosis Laser (MCML24004)?

Medicell Mycosis Laser (MCML24004) is manufactured by Medicell Healthcare Co.,LTD.

What is the FDA product code for Medicell Mycosis Laser (MCML24004)?

The FDA product code for Medicell Mycosis Laser (MCML24004) is PDZ.

Related Devices (Code: PDZ)

K153164LunulaLaserErchonia Medical, Inc. K190034REMY Medical Therapy Laser SystemFootdocprenur, LLC K211265TFX-LT2000 Therapy LightToefx, Inc. K221363AF LaserShenB Co., Ltd. K241116Onycho Laser VTerasysd&C, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑