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

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Product code

OHT
21 CFR 878.4810

Predicate devices

2

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

2

K251914 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251914 as a predicate