Cytotoxicity Test
Non-toxic to human skin cells, ensuring a safe healing environment
Skin Irritation Test
Verified as a non-irritant, safe for even the most sensitive post-surgery skin
Sensitization Test
Hypoallergenic formula with zero sensitization recorded in clinical trials
ISO 13485 Quality Management System for Medical Device
Non-toxic to human skin cells, ensuring a safe healing environment
Current Good Manufacturing Practice
Verified as a non-irritant, safe for even the most sensitive post-surgery skin
US FDA 21 CFR Part 820 (QSR)
Our production processes are aligned with the rigorous quality system requirements of the US FDA
Raw Materials from FDA-Compliant Facility
Our high-purity raw materials are sourced exclusively from facilities that strictly adhere to FDA CGMP (Current Good Manufacturing Practice) standards.
Stringent Quality Management Systems
Our core suppliers maintain robust FDA-recognized Quality Management Systems (QMS), ensuring exceptional batch-to-batch consistency and product reliability.
FDA Master File (MAF) Support
The key ingredients used in Safiscar™ are supported by active FDA MAFs (Master Files), ensuring comprehensive regulatory documentation and ingredient transparency.
How it works
Simple, Convenient, Effective
Clean
Ensure the scar area is thoroughly cleansed and patted dry
Apply
Apply a very thin layer of Safiscar over the scar without rubbing. Use twice daily.
Dry
Allow 2-3 minutes to air-dry before applying clothing or makeup
