Device Classification Name |
Light Based Over The Counter Wrinkle Reduction
|
510(k) Number |
K230124 |
Device Name |
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) |
Applicant |
Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands |
Hague,
NL
2500
|
|
Applicant Contact |
Alain Dijkstra |
Correspondent |
Light Tree Ventures Europe B.V. |
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands |
Hague,
NL
2500
|
|
Correspondent Contact |
Alain Dijkstra |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/17/2023 |
Decision Date | 03/15/2023 |
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
|
|
|