Manufacturer
Miley Technology (Hebei) Co., Ltd.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)
Miley Technology (Hebei) Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251914
- Device name
- 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)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-23
- Decision date
- 2025-09-15
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. The device is used for adults with Fitzpatrick skin types 1-IV.
Intended Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. The device is used for adults with Fitzpatrick skin types 1-IV.
Device Description
IPL Hair Removal Device is a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a finger switch or auto light emission. If the light outlet of the device is not fully contact with the skin, the device cannot emit the treatment light pulses. The device includes MLY-M011, MLY-M012, MLY-M013, MLY-M015, MLY-T001, MLY-T002 six models. There is difference in product appearance, cooling function, physical product dimension, indicator display and spot size, but their intended use, performance, output energy, structure design and operation are basically identical. MLY-M011 has no cooling function, while other models (MLY-M012, MLY-M013, MLY-M015, MLY-T001, MLY-T002) have cooling function.
Summary parsed at:2026-06-11 04:31:03 UTC
Predicate devices
2IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
K251914 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251914 as a predicate
