Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K143199 |
Device Name |
Capillus 272 Pro |
Applicant |
Capillus, LLC |
1430 South Dixie Highway, Suite 304 |
Coral Gables,
FL
33146
|
|
Applicant Contact |
Frances Pina Brea |
Correspondent |
Capillus LLC |
1430 South Dixie Hwy |
Suite 304 |
Coral Gables,
FL
33146
|
|
Correspondent Contact |
Patricia Schnoor |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 11/06/2014 |
Decision Date | 01/29/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01967277
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|