Edit by Christine
Email: info@rimlessindustry.com
Reborn Poly L-lactic acid (PLLA) has successfully obtained Class III medical device approval in Russia through its authorized partner.
The successful approval, achieved after five years of regulatory commitment, reflects the product’s validated safety, performance, and long-term clinical value.
This milestone establishes a solid foundation for further international development and clinical application.
Approved Within a Structured Regulatory Framework
In Russia, medical devices are regulated under the supervision of Roszdravnadzor.
Within this system, Class III represents the highest risk classification, requiring comprehensive evaluation of:
- Safety and biocompatibility
- Clinical-related performance
- Technical documentation
- Manufacturing and quality standards
The approval process involves multi-stage regulatory review and may include on-site inspections of manufacturing facilities, ensuring compliance with established requirements.
A Multi-Year Commitment Reflecting Product Confidence
The approval was completed by our authorized partner, Realine Group, following a multi-year regulatory process.
This level of commitment indicates strong confidence in the product’s clinical application and long-term potential in the aesthetic field.
Regulatory Details
- Product Name: Implant for injectable wrinkle correction and volume restoration "Reborn" (Poly L-lactic acid)
- Registration Number: Рег.номер мед.изделия Г004-00110-00/04360185
- Classification: Class III Medical Device
- Registered by: Realine Group
- From Approval to Clinical Practice
Following approval, Reborn PLLA has been introduced into clinical practice in aesthetic settings.
Practitioners are applying PLLA-based treatments for:
- Facial volume restoration
- Skin quality improvement
- Collagen stimulation
- Body contouring
This progression from regulatory approval to clinical use supports its practical applicability in real treatment scenarios.
What This Means for Partners
For distributors and aesthetic professionals, this milestone provides:
- Entry into a regulated and approved product category
- Reduced uncertainty through completed regulatory processes
- Established clinical application pathways
- Alignment with the growing demand for biostimulator-based treatments
This is a product supported by regulatory validation and clinical application.
A Biostimulator Approach to Aesthetic Medicine
Reborn PLLA is designed to stimulate collagen production over time, supporting:
- Gradual and natural-looking results
- Improved skin structure
- Long-term aesthetic outcomes
- Ongoing International Development
With successful approval and clinical introduction in Russia, Reborn PLLA continues to expand into additional markets.
Contact & Partnership
For distribution opportunities or product information, please contact us: