Device Classification Name |
Light Based Over-The-Counter Hair Removal
|
510(k) Number |
K181121 |
Device Name |
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro |
Applicant |
Home Well Trading LTD |
Omar Hodge Building, Road Town |
Tortola,
VG
1110
|
|
Applicant Contact |
Martin Gurovich |
Correspondent |
Home Well Trading LTD |
Omar Hodge Building, Road Town |
Tortola,
VG
1110
|
|
Correspondent Contact |
Martin Gurovich |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/30/2018 |
Decision Date | 06/28/2018 |
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
|