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510(k) Data Aggregation
K Number
K221679Device Name
IPL Hair Remover, Model: G993, G996, G998 and G885
Manufacturer
Date Cleared
2022-07-07
(28 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Mywin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
IPL Hair Remover Device (Model: G993, G996, G998 and G885), is an over-the-counter use device for removal of unwanted body and/or facial hair based on Intense Pulsed Light (IPL) treatment. The device package includes IPL DEVICE, Power supply and User manual. It is supplied by AC power supply (Input 100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device is equipped with a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Remover Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered for pulse emitting. The device can be used for large areas on legs, arms, back and abdomen. The product can flash for 100,000 times.
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K Number
K211368Device Name
IPL Hair Remover, Model: G993, G996, G998 and G885
Manufacturer
Date Cleared
2021-10-04
(153 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Mywin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IPL Hair Remover Device, Model: G993, G996, G998 and G885 is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Device Description
IPL Hair Remover, Model: G993, G996, G998 and G885 is a small prescription-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE. Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm (H*W*D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
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