Medicell Mycosis Laser (MCML24004)— 510(k) K253960
Substantially EquivalentMedicell Healthcare Co.,LTD
FDA 510(k) clearance K253960 for Medicell Mycosis Laser (MCML24004), Substantially Equivalent on 2026-03-09. Applicant: Medicell Healthcare Co.,LTD. Device class: 2.
Summary
Medicell Healthcare's Medicell Mycosis Laser (MCML24004) is filed under PDZ, lasers for temporary increase of clear nail in patients with onychomycosis. That's the code's name; the record doesn't describe the laser itself.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Medicell Healthcare filed from Incheon, South Korea. The decision came 89 calendar days after receipt (December 10, 2025 to March 9, 2026).
Clearance details
- Applicant
- Medicell Healthcare Co.,LTD
- Product code
- Product code PDZ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Incheon, KR
Recent devices under product code PDZ
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