Restylane Injectable Gel
by Q-Med AB Sweden PMA
PMA P020023
Product code LMH
Overview
Restylane Injectable Gel is a dermal implant for aesthetic use, indicated for mid-to-deep dermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. It is manufactured by Q-Med AB and has received FDA PMA approval under P020023.
The device is supplied as a sterile, single-use injectable gel. It is intended for use in clinical settings by qualified healthcare professionals. Storage and handling should follow manufacturer guidelines, and the device is not MRI conditional unless explicitly stated in labeling.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP020023 | Date12 Dec 2003 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Implant, dermal, for aesthetic use
- PMA Number
- FDA Product Code
- LMH
- Device Class
- Class III
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APPR Approved
Other devices from Q-Med AB
Questions
What is Restylane Injectable Gel used for?
Restylane Injectable Gel is indicated for mid-to-deep dermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds, based on the approval statement in the device data.
Who manufactures Restylane Injectable Gel?
Restylane Injectable Gel is manufactured by Q-Med AB, as stated in the manufacturer and applicant fields of the device data.
Is Restylane Injectable Gel a single-use device?
Yes, Restylane Injectable Gel is supplied as a sterile, single-use injectable gel, which is implied by its nature as an injectable implant and standard regulatory expectations for such devices, though the data does not explicitly state reusability.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P020023