Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K162071 |
Device Name |
IllumiFlow Laser Cap |
Applicant |
EGLOBAL, LLC |
10115 E BELL RD STE 107 |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
WAYNE DESTEFANO |
Correspondent |
LIZA BURNS AND ASSOCIATES |
6469G KAWAIHAU RD |
KAPAA,
HI
96746
|
|
Correspondent Contact |
LIZA BURNS |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 07/27/2016 |
Decision Date | 02/24/2017 |
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
|
|
|