Lipoderma™ 1.5cc

Human Adipose Tissue Allograft

Lipoderma™ 1.5cc is a minimally manipulated human adipose tissue allograft intended for homologous use and processed by FDA-registered tissue establishments in Florida operating under applicable FDA regulations and American Association of Tissue Banks (AATB) standards.

Each unit undergoes donor screening, donor eligibility determination, infectious disease testing, tissue recovery, processing, storage, and distribution in accordance with applicable Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) requirements. FDA regulations require tissue establishments to maintain Current Good Tissue Practice (CGTP) standards designed to prevent the introduction, transmission, or spread of communicable disease.

Lipoderma™ is regulated as a Section 361 Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) under 21 CFR Part 1271. Products meeting the applicable criteria under Section 361 are regulated through the HCT/P framework and are not subject to FDA premarket approval, clearance, or biologics licensing requirements.

Key Differentiators

• 1.5cc presentation for precise procedural use
• Human adipose tissue allograft
• Processed in FDA-registered tissue establishments
• Manufactured under Current Good Tissue Practice (CGTP) requirements
• Donor screening and testing performed in accordance with FDA regulations
• Traceability and tissue tracking maintained throughout processing and distribution
• Produced utilizing standards consistent with AATB-accredited tissue banking practices

Regulatory Information

Lipoderma™ is regulated under Section 361 of the Public Health Service Act and 21 CFR Part 1271 as an HCT/P. The product has not been evaluated by the FDA for safety or effectiveness through a premarket approval, clearance, or biologics license application process because such approval is not required for products that meet the criteria for regulation solely under Section 361.

Learn More

• FDA Tissue & Tissue Products Overview
• FDA 21 CFR Part 1271 HCT/P Regulations
• FDA Guidance on Minimal Manipulation and Homologous Use
• AATB Standards for Tissue Banking