510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253960Substantially Equivalent

Medicell Mycosis Laser (MCML24004)

Medicell Healthcare Co.,LTD, Incheon, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253960 is the FDA 510(k) clearance record for Medicell Mycosis Laser (MCML24004), a class II device, cleared for Medicell Healthcare Co.,LTD on under FDA product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis). FDA's definition for product code PDZ reads: "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.)". FDA records list one 510(k) clearance for Medicell Healthcare Co.,LTD. As of , FDA records show no recalls naming K253960.

Clearance record

Decision date
Received
(89 days to decision)
Product code
PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medicell Healthcare Co.,LTD #B1040 Incheon Global Campus, Incheon, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDZ

Trailing 12 months
1 clearance under product code PDZ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PDZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260