|
Device |
laser, comb, hair |
Definition |
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v |
Product Code | OAP |
Regulation Number |
890.5500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADVIHAIR S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUXO HAIR, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOPHOTAS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPILLUS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVERSION LABS, PR, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN LESCOLTON INTELLIGENT ELECTRICAL APPLIANCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN LESCOLTON MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FREEDOM LASER THERAPY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HUBEI YJT TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KAM YUEN PLASTIC PRODUCTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAM YUEN PLASTIC PRODUCTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KUNSHAN BELLA OPTICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEANA ORDERS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LG ELECTRONICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIGHT TREE VENTURES EUROPE B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LUMENIS BE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NATURE INCREDIBLE INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OMM IMPORTS, INC. D/B/A ZERO GRAVITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PJM WORLDWIDE, LLC D/B/A PHOENIX MEDICAL TECHNOLOGY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANG FA BIOTECHNOLOGY CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN COSBEAUTY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SLINPH TECHNOLOGIES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRANSDERMAL CAP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WON TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WONTECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XTRALLUX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
Y&J BIO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YIBIN YINGTONG INTELLIGENT TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|