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510(k) Data Aggregation
K Number
K240583Device Name
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
Manufacturer
Shenzhen Beauty Every Moment intelligent electric Co., Ltd.
Date Cleared
2024-06-18
(109 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beauty Every Moment intelligent electric Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.
IPL Home Use Hair Removal Device includes D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.
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K Number
K211185Device Name
IPL Home Use Hair Removal Device
Manufacturer
Shenzhen Beauty Every Moment intelligent electric Co., Ltd.
Date Cleared
2021-12-20
(244 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beauty Every Moment intelligent electric Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
The IPL Home Use Hair Removal 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 Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
The IPL Home Use Hair Removal Device includes D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents and the number of button, lamp cartridge's quantity and appearance; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.
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