|
Device |
powered light based non-laser surgical instrument with thermal effect |
Definition |
A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light. |
Product Code | ONF |
Regulation Number |
878.4810
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BEIJING ADSS DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING GLOBALIPL DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING SUPERLASER TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
E-SWIN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEBEI ZHEMAI TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAM YUEN PLASTIC PRODUCTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUVO MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGDONG HUAMEI TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI OMNI LASER SKINOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ACCOMPANY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN BOYUAN INTELLIGENT ELECTRONIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IONKA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MYWIN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TENTECH CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULIKE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENUS CONCEPT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
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