FDA.reportPublic FDA data

Restylane-L

Primary DI
07331689120288
Brand
Restylane-L
Company
Q-Med AB
Model
Gel 1.0 ml syringe
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040024143

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040024143RESTYLANE INJECTABLE GELQ-Med AB2005-03-25LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331689120288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331689120288073316891202887331689120288

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to direct sunlight
Special Storage Condition, Specify00Do Not Freeze
Special Storage Condition, Specify00Refrigeration not required
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
355371873
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07331689120301Restylane Lyft with LidocaineGel 1 mL Syringe2026-04-30
07331689120318Restylane Lyft with LidocaineGel 1 mL Syringe-Demo2026-04-30
07331689120325Restylane EyelightGel 0.5 mL Syringe2026-04-30
07331689120332Restylane EyelightGel 0.5 mL Syringe-Demo2026-04-30
07331689120295Restylane-LGel 1.0 ml syringe - demo2026-04-29
07331689121445Restylane ContourGel 1 mL Syringe2024-10-31
07331689121452Restylane ContourGel 1 mL Syringe - Demo2024-10-31
07331689116014Restylane RefyneGel 1 mL Syringe2024-05-03
07331689116021Restylane RefyneGel 1 mL Syringe-Demo2024-05-03
07331689116038Restylane DefyneGel 1 mL Syringe2024-05-03
07331689116045Restylane DefyneGel 1 mL Syringe-Demo2024-05-03
07331689116052Restylane KysseGel 1 mL Syringe2024-05-03
07331689116069Restylane KysseGel 1 mL Syringe-Demo2024-05-03
07331689116113Sculptra1 vial pack-Sample2024-05-03
07331689117035RestylaneGel 1 mL Syringe2024-05-03
07331689117042Restylane-LGel 1.0 ml syringe - Demo2024-05-03
07331689117066Restylane Lyft with LidocaineGel 1.0 ml syringe - Demo2024-05-03
07331689117134Restylane-LGel 1 mL Syringe2024-05-03
07331689117141Restylane Lyft with LidocaineGel 1 mL Syringe2024-05-03
07331689116106Sculptra 2 vial pack 2024-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08437027710070RESTYLANE KYSSESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710087RESTYLANE LYFT WITH LIDOCAINESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710094RESTYLANE REFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
07640173236177RHA® 3 MepiTeoxane SALMH2025-05-01
07640173236108RHA® 3 MepiTeoxane SALMH2025-05-01
03760172161264EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161271EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161288EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161295EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161301EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161318EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03770034301103RadiesseUNIVERDERMLMH2024-12-02
03770034301097RadiesseUNIVERDERMLMH2024-12-02