Table 3. Characteristics of Liquid-Type PDO and CaHA Products

No Product name Manufacturer (Country) Principal component Formulation Volume Excipients Anesthetic Injection method Indications MFDS§ approval International certification
1 ULTRACOL LIV Co., Ltd. (Korea) PDO§ Powder (PDO+SCMC): 50·100·150·200 ㎎/vial SCMC§ None 25G needle/25G cannula Nasolabial folds Tissue repair material (No. 20-598, 2020.07.22) CE§(2021)
2 RADIESSE + Lidocaine* Merz North America, Inc. (USA) CaHA§ Suspension 1.5 ㎖/syringe SCMC Lidocaine hydrochloride0.3% (pre-mixed) 27G needle (PFS§) Facial wrinkles(nasolabial folds, marionette lines, jawline), cheek volume augmentation, dorsal hand wrinkles Tissue repair material (No. 17-91, 2017.03.07) FDA§ (2009), CE (2016)
3 VOLassom, Facetem, etc. CGBIO (Korea) CaHA Suspension 0.3·0.8·1.0·1.5 ㎖/syringe SCMC, glycerin, water None Injection (PFS) Facial wrinkles Tissue repair material (No. 11-1324, 2011.12.05) CE (2020)
4 RADIESSE Merz North America, Inc. (USA) CaHA Suspension 1.5 ㎖/syringe Gel, sterile distilled water for injection, glycerol, SCMC None 27G needle or larger diameter Facial wrinkles(nasolabial folds), cheek volume augmentation, dorsal hand volume restoration, HIV-associated facial fat loss Tissue repair material (No. 10-1238, 2010.11.17) FDA (2006), CE (2004)
Model name: RADIESSE + Lidocaine InjecTable Implant 1.5㎖ (also known as RADIESSE WITH LIDOCAINE).
All product names under this approval: VOLassom, Facetem, NUIT, Facetem S, VOLassom CaHA, DCLASSY CaHA 0.8/1.5.
Model name: RADIESSE InjecTable Implant 1.5㎖.
PDO, polydioxanone; CaHA, calcium hydroxyapatite; SCMC, sodium carboxymethylcellulose; MFDS, Ministry of Food and Drug Safety; CE, Conformité Européenne; FDA, Food and Drug Administration; PFS, prefilled syringe.