|
Device |
light based over-the-counter hair removal |
Regulation Description |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
Definition |
Over-the-counter device uses thermal energy to kill hair follicles for hair removal. |
Product Code | OHT |
Regulation Number |
878.4810
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
CYDEN LIMITED |
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SUBSTANTIALLY EQUIVALENT
|
7
|
DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO.,LTD. |
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SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO. LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN LIDE ELECTRIC APPLIANCE CO., LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
FOREO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN JINDI ELECTRIC APPLIANCE CO.,LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
GLAN ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU HAOXINGWAN TECHNOLOGY CO., LTD. |
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SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN GUANGYE BIOTECHNOLOGY CO., LTD. |
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SUBSTANTIALLY EQUIVALENT
|
1
|
ILUMINAGE BEAUTY CO., LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVYLASER (BEIJING) TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAM YUEN PLASTIC PRODUCTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUMENESSA CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MILEY TECHNOLOGY(HEBEI) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MORLASER SHENZHEN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QIAOCHENG LI (DONGGUAN) MEDICAL INSTRUMENTS CO., LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN BEAUTY EVERY MOMENT INTELLIGENT ELECTRIC CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN BORRIA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BORRIA TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CENTURY DONGYUAN TECHNOLOGY CO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN DESIDA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN FANSIZHE SCIENCE AND TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN GOODWIND TECHNOLOGY DEVELOPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN GREATRO ELECTRONIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN GREATRO ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN GSD TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HUARUIBO ELECTRIC APPLIANCES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IONKA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ISHINE TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIANCHAO INTELLIGENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN JIANRONG BIOMEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIZHIMEI TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JUNBOBEAUTY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JUNMEI TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN KOLI TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN LESCOLTON ELECTRICAL APPLIANCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LESCOLTON ELECTRICAL APPLIANCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LIZBELLA TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MAREAL TECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MEIK BEAUTY INDUSTRY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MISMON TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MYWIN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN NOBLE SMART MANUFACTURING TECH CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN QIANYU TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN QIAOCHENGLI TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN SEMLAMP INTELLIGENT TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN SHUGE MEDICAL BEAUTY DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN ULIKE SMART ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN WEIKAI TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN WOCHUAN ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN XIAZHIFENG ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YANG WO ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YANGYI TECHNOLOGY ., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YUWEI ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MLAY INTELLIGENT TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ULIKE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULIKE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUHAN LOTUXS TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHONGSHAN BISEN PLASTIC ELECTRONIC PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHONGSHAN QIZHE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
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|
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