FDA Product Code LCJ: Tissue Expander And Accessories
Leading manufacturers include Mentor Worldwide, LLC, Sientra, Inc. and Motiva USA, LLC.
FDA 510(k) Cleared Tissue Expander And Accessories Devices (Product Code LCJ)
About Product Code LCJ - Regulatory Context
510(k) Submission Activity
55 total 510(k) submissions under product code LCJ since 1977, with 55 receiving FDA clearance (average review time: 142 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LCJ have taken an average of 75 days to reach a decision - down from 147 days historically, suggesting improved FDA processing for this classification.
LCJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →