|
Device | Restylane® Eyelight |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S135 |
Date Received | 11/07/2022 |
Decision Date | 05/08/2023 |
Product Code |
LMH |
Docket Number | 23M-1986 |
Notice Date | 05/19/2023 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT04154930
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the improvement of infraorbital hollowing in patients over the age of 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |