IPL Hair Removal Device (6 models)— 510(k) K251914
Substantially EquivalentMiley Technology (Hebei) Co., Ltd.
FDA 510(k) clearance K251914 for IPL Hair Removal Device (6 models), Substantially Equivalent on 2025-09-15. Applicant: Miley Technology (Hebei) Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)
- Applicant
- Miley Technology (Hebei) Co., Ltd.
- Product code
- Product code OHT
- 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
- Handan, CN
Recent devices under product code OHT
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261975 — Braun Aura 7 (6041)
- K261977 — Braun Aura 9 (6042)
- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
More clearances from Miley Technology (Hebei) Co., Ltd.
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