Device Classification Name |
Light Based Over-The-Counter Hair Removal
|
510(k) Number |
K172791 |
Device Name |
Lumilisse IPL Hair Remover |
Applicant |
Conair Corporation |
One Cummings Point Road |
Stamford,
CT
06902
|
|
Applicant Contact |
Mike Cantrell |
Correspondent |
Smith Associates |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/15/2017 |
Decision Date | 01/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|