Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K172968 |
Device Name |
Hair Up |
Applicant |
Y&J BIO Co., Ltd. |
No. C-413, Munjeong Hyundai Knowledge Center 1, 7 |
Beobwon-ro 11-gil |
Seoul,
KR
05836
|
|
Applicant Contact |
Kwang Sic Kim |
Correspondent |
BT Solutions, Inc. |
Unit 502, 148 Yeoksam-ro |
Seoul,
KR
06249
|
|
Correspondent Contact |
Mina Joo |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 09/26/2017 |
Decision Date | 01/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|