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510(k) Data Aggregation
K Number
K250131Device Name
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
Manufacturer
Date Cleared
2025-03-19
(61 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Mustech Electronics Co., Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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, 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.
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