Restylane® Eyelight
FDA premarket approval P040024/S135 · decided 2023-05-08
Approval details
- PMA number
- P040024
- Supplement
- S135
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane® Eyelight
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2022-11-07
- Decision date
- 2023-05-08
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the improvement of infraorbital hollowing in patients over the age of 21.
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