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Proluma™ PLLA Launch and CE Certification

2025-02-17

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Completing the Proluma™ biostimulator line: PLLA 365 mg for deep structural volume restoration
Paris, France — 17 February 2025 — Genèse Labs has launched Proluma™ PLLA 365 mg, an injectable collagen biostimulator, together with CE certification as a Class III medical device — completing a two-formulation Proluma™ line alongside PDLLA 200 mg.

• Injectable collagen biostimulator based on poly-L-lactic acid (PLLA) 365 mg
• CE certification as a Class III medical device, meeting European safety and performance requirements
• Specialised for structural volume restoration in the deeper layers, complementing PDLLA 200 mg for early intervention
• Two formulations allow practitioners to match product to depth, indication and patient profile
Why a Second Formulation
Launched in 2024, Proluma™ PDLLA 200 mg established itself as a natural, easy-to-handle option for early signs of ageing in patients in their thirties and forties. Practitioners, however, have consistently asked for an option suited to more advanced volume loss — hollowing of the temples and cheeks, and reduced structural support in the lateral face. Proluma™ PLLA 365 mg answers that request. PLLA is an L-isomer polymer that degrades more slowly in the body than PDLLA, making it well suited to building a firmer, longer-term collagen framework.
How PLLA Works
PLLA works through the same principle of neocollagenesis as PDLLA. The injected microparticles activate fibroblasts, and new collagen accumulates gradually over weeks and months, restoring tissue volume and firmness. PLLA is ultimately hydrolysed into lactic acid, which is metabolised into carbon dioxide and water and eliminated from the body.
PDLLA and PLLA at a Glance
• Primary role — PDLLA 200 mg: early intervention, balanced collagen stimulation / PLLA 365 mg: structural volume restoration in the deeper layers
• Typical patient — PDLLA: early signs of ageing (30s–40s) / PLLA: more advanced volume loss
• Result profile — both deliver gradual improvement that develops naturally over time


The Significance of CE Certification
Under the EU Medical Device Regulation (Regulation (EU) 2017/745), Class III is the highest risk class, requiring notified-body assessment of clinical evaluation and quality management systems. CE certification for Proluma™ PLLA reaffirms the regulatory-first development principle Genèse Labs has followed since its foundation.

“PDLLA gave practitioners a gentle entry point; PLLA adds the structural depth to treat more advanced volume loss. Together they make Proluma™ a complete biostimulation platform.” — Genèse Labs, Product statement

About Genèse Labs 
Genèse Labs is a Paris-founded aesthetic company dedicated to science-based, regulatory-led product development across body contouring, collagen biostimulation, hyaluronic acid fillers and regenerative skincare. Since its foundation in 2019, the company has built its portfolio — including the RG Body Filler line, Proluma™ (PDLLA, PLLA and RH Collagen), Réluma, Citrus Bottle™, Exoluma™ (Human, Plant and Exo-PDRN) and Exo-Mask — on three principles: scientifically verifiable formulations, regulatory compliance in every market entered, and continuous engagement with the international clinical and academic community. Genèse Labs partners with dermatologists, aesthetic physicians and distributors worldwide to advance the standard of modern aesthetic medicine. For more information: www.geneselabs.net.


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