PMA P040024S143

Device: Restylane®-L 1 mL; Restylane® Lyft™ with Lidocaine 1 mL; Restylane® Eyelight™ 0.5 mL
Applicant: Q-Med AB
PMA number: P040024
Supplement: S143
Product code: LMH
Decision date: 2026-01-29
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: multiple changes including, (1) primary packaging, (2) a new needle and hub, (3) secondary packaging updates, (4) inclusion of a treatment card for recording patient and treatment information, (5) an updated IFU with updated needle assembly instructions adapted for the new syringe and the needle and information regarding the new treatment card, (6) a new syringe label, (7) a new semi-automatic downstream manufacturing line, and (8) a new transport box to fit the new smaller secondary packaging.

Current openFDA PMA Record#

Device: Restylane®-L 1 mL; Restylane® Lyft™ with Lidocaine 1 mL; Restylane® Eyelight™ 0.5 mL
Applicant: Q-Med AB
PMA number: P040024
Supplement: S143
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-01-29
Decision code: APPR
Date received: 2025-07-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: multiple changes including, (1) primary packaging, (2) a new needle and hub, (3) secondary packaging updates, (4) inclusion of a treatment card for recording patient and treatment information, (5) an updated IFU with updated needle assembly instructions adapted for the new syringe and the needle and information regarding the new treatment card, (6) a new syringe label, (7) a new semi-automatic downstream manufacturing line, and (8) a new transport box to fit the new smaller secondary packaging.