Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K173843 |
Device Name |
illumiflow 148 Laser Cap |
Applicant |
EGlobal, LLC |
10115 E Bell Rd |
Suite 107 |
Scottsdale,
AZ
85260
|
|
Applicant Contact |
Wayne De Stefano |
Correspondent |
Liza Burns and Associates |
6469 G Kawaihau Road |
Kapaa,
HI
96746
|
|
Correspondent Contact |
Liza Burns |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 12/18/2017 |
Decision Date | 01/26/2018 |
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
|
|
|