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510(k) Data Aggregation
K Number
K210311Device Name
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
Manufacturer
Shenzhen Mismon Technology Co., Ltd.
Date Cleared
2021-07-23
(170 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Mismon Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Device Description
The Home Use IPL Beauty Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. Of which, the Device includes MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6 and MELSYA-M7 six models. All have adopted the same structure design, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.
The difference of all models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of model MS-208B, MS212B and MELSYA-M6 is designed to 3.6cm², model MS-216B, MS-218B and MELSYA-M7 is designed to 3.0 cm2, as well as the energy density of the all models is in the range of 2.0~5.1J/cm².
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K Number
K180016Device Name
Home Use IPL Beauty Device
Manufacturer
Shenzhen Mismon Technology Co., Ltd
Date Cleared
2018-03-20
(77 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Mismon Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Device Description
The Home Use IPL Beauty Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. Of which, the Device includes MELSYA-M5 and MS-206B two models. Both have adopted the same structure design, consisting of Hair removal device main body and power adapter two parts, and a hair removal lamp located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.
The difference of MELSYA-M5 and MS-206B two models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of MELSYA-M5 is 3.9cm² and MS-206B is 3.0 cm², as well as the energy density of the both models is 5.5 J/cm2.
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