Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K222081 |
Device Name |
ID-510 iRestore Elite |
Applicant |
Freedom Laser Therapy, Inc. |
16782 Von Karman Avenue, Unit 15 |
Irvine,
CA
92606
|
|
Applicant Contact |
Wei-Chih 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 | 07/15/2022 |
Decision Date | 10/13/2022 |
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
|
|
|