Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K242619 |
Device Name |
GroWell BT Hair Growth System (GW10042) |
Applicant |
Apira Science Inc |
409 Edmon Rd. NE Suite C |
Albuquerque,
NM
87107
|
|
Applicant Contact |
Ray Pizinger |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
Rm 2401 Zhenye International Business Center, |
No. 3101-90, Qianhai Road |
Shenzhen,
CN
518052
|
|
Correspondent Contact |
Tracy Che |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 09/03/2024 |
Decision Date | 12/02/2024 |
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
|
|
|