Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K192012 |
Device Name |
Capillus 112, Capillus 244 |
Applicant |
Capillus |
1715 NW 82nd Ave. |
Doral,
FL
33126
|
|
Applicant Contact |
Patricia Schnoor |
Correspondent |
Capillus |
1715 NW 82nd Ave. |
Doral,
FL
33126
|
|
Correspondent Contact |
Patricia Schnoor |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 07/29/2019 |
Decision Date | 09/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|