Device Classification Name |
laser, comb, hair
|
510(k) Number |
K213094 |
Device Name |
ID-500 iRestore Hair Growth System |
Applicant |
Freedom Laser Therapy, Inc. |
16782 Von Karman Avenue, Unit 15 |
Irvine,
CA
92606
|
|
Applicant Contact |
Wei-Chih (Kevin) Chen |
Correspondent |
Emergo Global Consulting, LLC |
2500 Bee Cave Road, Building 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Sharon Chen |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 09/24/2021 |
Decision Date | 12/22/2021 |
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
|
|
|