FDA.reportPublic FDA data

Dermal tissue reconstructive material, microbe-derived, anaesthetic

Definition
A 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.
GUDID devices
195
Last updated
2026-08-18 06:11:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07640123792982Belotero Volume (+) LidocaineANTEIS SA8716M02026-08-08
07640123792999Belotero Volume (+) LidocaineANTEIS SA8716M0S2026-08-08
07640123791138Belotero Balance (+) LidocaineANTEIS SA8705M02021-01-01
07640123791145Belotero Balance (+) LidocaineANTEIS SA8710M02023-06-01
07640123791220Belotero Balance (+) LidocaineANTEIS SA8705M0S2021-01-01
07640123791343Belotero Balance (+) LidocaineANTEIS SA8710M0S2023-06-01
00302995964122Restylane RefyneQ-Med ABGel 1 mL Syringe2022-12-13
00302995964139Restylane RefyneQ-Med ABGel 1.0 ml syringe - demo2022-12-13
00302995965129Restylane DefyneQ-Med ABGel 1 mL Syringe2022-12-13
00302995965136Restylane DefyneQ-Med ABGel 1.0 ml syringe - demo2022-12-13
00302995965525Restylane KysseQ-Med ABGel 1 mL Syringe2022-12-13
00302995965532Restylane KysseQ-Med ABGel 1.0 ml syringe - demo2022-12-13
03770034301103RadiesseUNIVERDERMLidocaine2024-12-02
04262533320055JuvedermArcera GmbHN/A2026-05-08
04262533320062RestylaneArcera GmbHN/A2026-05-08
07331689115468Restylane Kysse Q-Med ABGel 1 mL Syringe2020-06-08
07331689115475Restylane KysseQ-Med ABGel 1 mL Syringe - demo2020-06-08
07331689120288Restylane-LQ-Med ABGel 1.0 ml syringe2026-04-29
07331689120295Restylane-LQ-Med ABGel 1.0 ml syringe - demo2026-04-29
07331689120301Restylane Lyft with LidocaineQ-Med ABGel 1 mL Syringe2026-04-30
07331689120318Restylane Lyft with LidocaineQ-Med ABGel 1 mL Syringe-Demo2026-04-30
07331689120325Restylane EyelightQ-Med ABGel 0.5 mL Syringe2026-04-30
07331689120332Restylane EyelightQ-Med ABGel 0.5 mL Syringe-Demo2026-04-30
07540161860004JuvedermModern Supplies Medical Inc.Ultra Plus XC2024-07-30
07540161860011JuvedermModern Supplies Medical Inc.Ultra XC2024-07-30
07640173230045RHA® 3Teoxane SARHA® 3 (1mL)2020-05-30
07640173231653RHA® RedensityTeoxane SARHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2022-05-03
07640173232704RHA® 4Teoxane SARHA® 4 US 1.2ml Schott/2 needles TSK 27G1/22022-03-23
07640173233473RHA® 3 MepiTeoxane SARHA® 3 Mepi - TSK - US2024-10-18
07640173233480RHA® 4 MepiTeoxane SARHA® 4 Mepi - TSK - US2024-10-18
07640173233497RHA® Redensity™ MepiTeoxane SARHA® Redensity Mepi - Terumo - US2024-10-18
07640173233527RHA® 2 MepiTeoxane SARHA® 2 Mepi - Terumo - US2024-10-18
07640173234128RHA® 2Teoxane SARHA® 2 - Terumo - US2024-03-22
07640173234173RHA® 3Teoxane SARHA® 3 US 1ml Schott/2 aig. TSK 27G1/22024-03-18
07640173236177RHA® 3 MepiTeoxane SARHA® 3 Mepi - TSK - US2025-05-01
07640173236283RHA® Dynamic VolumeTeoxane SARHA® Dynamic Volume - TSK - US2025-12-18
10840228300066SkinviveAllergan, Inc.983072023-05-22
10840228302763SKINVIVE BY JUVEDERM XC 1ML SAMPLEAllergan, Inc.98307DB2024-04-10
10840228302770JUVEDERM ULTRA PLUS XC 1ML SAMPLEAllergan, Inc.94155DB2024-04-10
10840228302787JUVEDERM ULTRA XC 1ML SAMPLEAllergan, Inc.94154DB2024-04-10
10840228302794JUVEDERM VOLBELLA XC 1ML SAMPLEAllergan, Inc.96181DB2024-04-10
10840228302800JUVEDERM VOLBELLA XC 0.55ML SAMPLEAllergan, Inc.96183DB2024-04-10
10840228302817JUVEDERM VOLLURE XC 1ML SAMPLEAllergan, Inc.95661DB2024-04-10
10840228302824JUVEDERM VOLUMA XC 1ML SAMPLEAllergan, Inc.94640DB2024-04-10
10840228302831JUVEDERM VOLUX XC 1ML SAMPLEAllergan, Inc.200741282024-04-10
10888628000018JUVEDERM VOLUMA XCAllergan, Inc.946402014-09-17
10888628000063JUVEDERM ULTRA XCAllergan, Inc.94146-22014-09-17
10888628000070JUVEDERM ULTRA XCAllergan, Inc.938992014-09-17
10888628000087JUVEDERM ULTRA XCAllergan, Inc.941542014-09-17
10888628000094JUVEDERM ULTRA PLUS XCAllergan, Inc.94147-22014-09-17
10888628000100JUVEDERM ULTRA PLUS XCAllergan, Inc.939002014-09-17
10888628000117JUVEDERM ULTRA PLUS XCAllergan, Inc.941552014-09-17
10888628034488JUVEDERM VOLLURE XCAllergan, Inc.956612017-03-21
10888628043558JUVÉDERM VOLBELLA XCAllergan, Inc.961812017-11-02
10888628043749JUVÉDERM VOLBELLA XCAllergan, Inc.961832017-11-02
10888628044760JUVEDERM ULTRA XCAllergan, Inc.962072019-04-22
10888628044784JUVEDERM ULTRA PLUS XCAllergan, Inc.962092019-04-22
M2138063M0K15Radiesse (+) Lidocaine1.5cc Injectable ImplantMERZ NORTH AMERICA, INC.8063M0K12015-08-19
M2138063M0K25Radiesse (+) LidocaineMERZ NORTH AMERICA, INC.8063M0K22016-09-09
M2138067M0K15Radiesse (+) Lidocaine 0.8cc Injectable ImplantMERZ NORTH AMERICA, INC.8067M0K12015-08-19
07640173236276RHA® Dynamic VolumeTeoxane SARHA® Dynamic Volume - TSK - US2025-12-18
00362032907017saypha MagIQObagi Cosmeceuticals LLC395072025-11-27
00362032907024saypha MagIQ SAMPLEObagi Cosmeceuticals LLC397292025-11-27
08052570473434RadiesseDAMBO SRLNA2025-09-25
08437027710063RESTYLANE DEFYNESAIMA GLOBAL FARMA S.L.Gel 1 mL Syringe2025-06-30
08437027710070RESTYLANE KYSSESAIMA GLOBAL FARMA S.L.Gel 1 mL Syringe2025-06-30
08437027710087RESTYLANE LYFT WITH LIDOCAINESAIMA GLOBAL FARMA S.L.Gel 1 mL Syringe2025-06-30
08437027710094RESTYLANE REFYNESAIMA GLOBAL FARMA S.L.Gel 1 mL Syringe2025-06-30
07640173236108RHA® 3 MepiTeoxane SARHA® 3 Mepi - TSK - US2025-05-01
03760172161264EVOLYSSE FORMSYMATESEEVOF1F0012025-02-19
03760172161271EVOLYSSE SMOOTHSYMATESEEVOF1S0012025-02-19
03760172161288EVOLYSSE FORMSYMATESEEVOF1F001-S2025-02-19
03760172161295EVOLYSSE FORMSYMATESEEVOF1F001-D2025-02-19
03760172161301EVOLYSSE SMOOTHSYMATESEEVOF1S001-S2025-02-19
03760172161318EVOLYSSE SMOOTHSYMATESEEVOF1S001-D2025-02-19
03770034301097RadiesseUNIVERDERMLidocaine2024-12-02
03770034301110Restylane Eyelight UNIVERDERMInjectable Gel2024-11-25
07331689121445Restylane ContourQ-Med ABGel 1 mL Syringe2024-10-31
07331689121452Restylane ContourQ-Med ABGel 1 mL Syringe - Demo2024-10-31
07640173233367RHA® Redensity™ MepiTeoxane SARHA® Redensity Mepi - Terumo - US2024-10-18