Manufacturer
Mustech Electronics Co., LimitedIPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
Mustech Electronics Co., Limited
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
- K250131
- Device name
- IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-17
- Decision date
- 2025-03-19
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyFace
- 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 and/or facial hair.
Intended Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
IPL Hair Removal Device is an over-the-counter, home use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. The device includes 12 models, they are M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023. Those models with model name of 'M80XX' are equipped with cooling function for a better hair remove experience, while those of 'M70XX' have no cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit light pulses.
Summary parsed at:2026-06-11 04:27:28 UTC
Predicate devices
2Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K250131 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 K250131 as a predicate