Medical Grade PDLLA Raw Materials High Safety Long Lasting Facial Rejuvenation FDA
Basic Properties
Place of Origin:
CHINA
Brand Name:
FITAKH
Certification:
NMPA ISO13485 GMP
Model Number:
PDLLA04
Trading Properties
Minimum Order Quantity:
1
Price:
40USD
Payment Terms:
T/T
Supply Ability:
100000
Specifications
| Injectiondepth: | Deep Dermis To Subcutaneous Tissue | Storageconditions: | Store At 2-25°C, Protect From Light |
| Approvalstatus: | FDA Approved For Facial Lipoatrophy And Cosmetic Use | Contraindications: | Allergy To PLLA, Active Skin Infection, Autoimmune Diseases |
| Type: | Injectable Dermal Filler | Commoninjectionsites: | Nasolabial Folds, Cheeks, Temples, Chin |
| Indications: | Facial Volume Restoration, Wrinkle Correction, Skin Rejuvenation | Productname: | PLLA Dermal Filler |
| Treatmentsessions: | Typically 2-3 Sessions Spaced 4-6 Weeks Apart | Sideeffects: | Swelling, Redness, Bruising, Nodules |
| Mechanismofaction: | Stimulates Collagen Production | Formulation: | Powder To Be Reconstituted With Sterile Water |
| Activeingredient: | Poly-L-Lactic Acid (PLLA) | Durationofeffect: | Up To 2 Years |
| Onsetofeffect: | Gradual, Noticeable After 4-6 Weeks | ||
| High Light: | Medical Grade PDLLA Raw Materials,PDLLA Raw Materials High Safety,Facial Rejuvenation PDLLA Raw Materials |
||
Product Description
Medical-Grade PDLLA Filler with High Safety and Stable Long-Lasting For Facial Rejuvenation
PDLLA Dermal Filler
-
Technical Principle: Medical-grade PDLLA is an amorphous random copolymer polymerized by DL-lactic acid monomers, featuring a disordered molecular chain structure without regular crystal lattices. Different from crystalline PLLA, its non-crystalline structure delivers softer texture and more uniform tissue compatibility after subcutaneous injection. The core working mechanism relies on mild and steady ester bond hydrolysis in physiological environments. Polymer long chains are gradually decomposed into natural lactic acid, which is further metabolized into carbon dioxide and water with zero toxic residues. During the slow degradation process, PDLLA continuously activates dermal fibroblasts, promotes autologous collagen hyperplasia and regeneration, and realizes the dual effect of physical filling support and biological skin rejuvenation.
-
Production Process: PDLLA adopts strict medical-grade sterile polymerization and deep purification procedures. High-purity DL-lactic acid raw materials are screened and refined to remove impurities, moisture and invalid monomers. Precision ring-opening polymerization is carried out under constant temperature and pressure with controllable catalytic conditions to form uniform high-molecular-weight PDLLA polymers. Multiple devolatilization and ultra-filtration purification processes are applied to thoroughly eliminate residual catalysts and micro-impurities. The whole synthesis, granulation and packaging process is completed in Class 100 dust-free sterile workshops, ensuring ultra-low sensitization, stable molecular weight distribution and consistent batch quality for clinical aesthetic injection.
Core Technical Parameters
|
Parameter
|
Specification
|
|---|---|
|
Core Component
|
Medical-grade Poly-DL-Lactic Acid (PDLLA)
|
|
Purity
|
≥98%
|
|
Molecular Structure
|
Amorphous random copolymer
|
|
Molecular Weight
|
50,000–100,000 Da (customizable)
|
|
In-vivo Degradation Cycle
|
12–18 months
|
|
Biocompatibility Standard
|
ISO 10993 compliant
|
|
Final Degradation Products
|
Natural lactic acid, CO₂ and H₂O
|
