FDA.reportPublic FDA data

Restylane Kysse

Primary DI
08057607270123
Brand
Restylane Kysse
Company
NUVARA SRL
Model
N/A
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LMHImplant, Dermal, For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057607270123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057607270123080576072701238057607270123

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, microbe-derived, anaestheticA sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.

Regulatory Flags#

DUNS number
302780450
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057607270017DurolaneN/A2026-10-15
08057607270024EuflexxaN/A2026-10-15
08057607270031Juvederm VolbellaN/A2026-10-15
08057607270048Juvederm VoluxN/A2026-10-15
08057607270055Juvederm VolumaN/A2026-10-15
08057607270062MonoviscN/A2026-10-15
08057607270079OrthoviscN/A2026-10-15
08057607270086RadiesseN/A2026-10-15
08057607270093Restylane LidoN/A2026-10-15
08057607270109Restylane LyftN/A2026-10-15
08057607270116Restylane RefyneN/A2026-10-15
08057607270130Restylane DefyneN/A2026-10-15
08057607270147SculptraN/A2026-10-15
08057607270161SupartzN/A2026-10-15
08057607270178SynviscN/A2026-10-15
08057607270192Synvisc OneN/A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057607270031Juvederm VolbellaNUVARA SRLLMH2026-10-15
08057607270048Juvederm VoluxNUVARA SRLLMH2026-10-15
08057607270055Juvederm VolumaNUVARA SRLLMH2026-10-15
08057607270086RadiesseNUVARA SRLLMH2026-10-15
08057607270093Restylane LidoNUVARA SRLLMH2026-10-15
08057607270109Restylane LyftNUVARA SRLLMH2026-10-15
08057607270116Restylane RefyneNUVARA SRLLMH2026-10-15
08057607270130Restylane DefyneNUVARA SRLLMH2026-10-15
08057607270147SculptraNUVARA SRLLMH2026-10-15
07640123792982Belotero Volume (+) LidocaineANTEIS SALMH2026-08-08
07640123792999Belotero Volume (+) LidocaineANTEIS SALMH2026-08-08
04262487270222Radiesse (+) LidocainePharmamondis GmbHLMH2026-06-24
04262533320055JuvedermArcera GmbHLMH2026-05-08
04262533320062RestylaneArcera GmbHLMH2026-05-08
07331689120301Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120318Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120325Restylane EyelightQ-Med ABLMH2026-04-30
07331689120332Restylane EyelightQ-Med ABLMH2026-04-30
07331689120288Restylane-LQ-Med ABLMH2026-04-29
07331689120295Restylane-LQ-Med ABLMH2026-04-29
08437027710117SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
08437027710100SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
07640173236283RHA® Dynamic VolumeTeoxane SALMH2025-12-18
07640173236276RHA® Dynamic VolumeTeoxane SALMH2025-12-18
00362032907017saypha MagIQObagi Cosmeceuticals LLCLMH2025-11-27
00362032907024saypha MagIQ SAMPLEObagi Cosmeceuticals LLCLMH2025-11-27
07640123793309Belotero Balance LidocaineANTEIS SALMH2025-09-30
07640123793316Belotero Balance LidocaineANTEIS SALMH2025-09-30
08052570473434RadiesseDAMBO SRLLMH2025-09-25
08437027710063RESTYLANE DEFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30