Mustech Electronics Co., Limited
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
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
No later 510(k)s cite this device yet
Other submissions will appear here when they list K250131 as a predicate
