Lipoderma™ 10cc

Human Adipose Tissue Allograft

Lipoderma™ 10cc is a human adipose tissue allograft processed by FDA-registered tissue banks in Florida utilizing established tissue banking procedures designed to preserve tissue integrity while maintaining compliance with applicable federal regulations and industry standards.

The tissue is recovered from eligible donors and undergoes comprehensive donor screening, infectious disease testing, processing, storage, and distribution in accordance with FDA requirements governing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Tissue establishments are required to operate under Current Good Tissue Practice (CGTP) standards intended to reduce the risk of communicable disease transmission.

Lipoderma™ is regulated as a Section 361 HCT/P under the Public Health Service Act and 21 CFR Part 1271. Products regulated solely under Section 361 are not required to obtain FDA premarket approval, FDA clearance, or a biologics license prior to distribution when they meet the applicable regulatory criteria.

Key Differentiators

• 10cc presentation for larger-volume procedural requirements
• Human adipose tissue allograft
• Processed and distributed through FDA-registered tissue establishments
• Manufactured under Current Good Tissue Practice (CGTP) requirements
• Donor screening and testing conducted pursuant to FDA regulations
• Full tissue traceability and chain-of-custody documentation
• Produced in accordance with recognized tissue banking standards

Quality & Compliance

Tissue establishments accredited by the American Association of Tissue Banks (AATB) adhere to comprehensive standards governing donor qualification, tissue processing, storage, recordkeeping, quality systems, and distribution. AATB accreditation is recognized throughout the tissue banking industry as a benchmark for operational excellence and quality assurance.

Regulatory Information

Lipoderma™ is regulated under Section 361 of the Public Health Service Act and 21 CFR Part 1271. As a 361 HCT/P, the product is regulated through FDA tissue regulations rather than the biologics approval pathway. The product has not been reviewed by FDA for safety or effectiveness through a premarket approval or biologics licensing process because such approval is not required for qualifying Section 361 HCT/Ps.

Learn More

• FDA Tissue & Tissue Products Overview
• FDA Tissue Establishment Registration Information
• FDA HCT/P Regulations (21 CFR Part 1271)
• AATB Accreditation Program