LCJ

FDA Product Code LCJ: Tissue Expander And Accessories

Leading manufacturers include Mentor Worldwide, LLC, Allergan and Sientra, Inc..

55
Total
55
Cleared
142d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 75d recently vs 147d historically

FDA 510(k) Cleared Tissue Expander And Accessories Devices (Product Code LCJ)

55 devices
1–24 of 55
Cleared Jan 16, 2026
Natrelle 133S Tissue Expanders
K254126
AbbVie
General & Plastic Surgery · 28d
Cleared Apr 24, 2025
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
K242963
Mentor Worldwide, LLC
General & Plastic Surgery · 211d
Cleared Jan 12, 2025
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander
K243836
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared Aug 02, 2024
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
K241918
Mentor Worldwide, LLC
General & Plastic Surgery · 32d
Cleared Oct 13, 2023
Motiva Flora SmoothSilk Tissue Expander
K211676
Motiva USA, LLC
General & Plastic Surgery · 864d
Cleared Jun 08, 2023
AlloX2 Pro Tissue Expanders
K214124
Sientra, Inc.
General & Plastic Surgery · 525d
Cleared May 10, 2023
Sientra, inc. Portfinder
K221127
Sientra, Inc.
General & Plastic Surgery · 387d
Cleared Dec 21, 2018
Natrelle 133 Plus MICROCELL Tissue Expander
K180826
Allergan
General & Plastic Surgery · 266d
Cleared Sep 25, 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335
Mentor Worldwide, LLC
General & Plastic Surgery · 28d
Cleared Aug 29, 2018
Natrelle 133S Tissue Expander
K182054
Allergan
General & Plastic Surgery · 29d

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 510(k) Review Time - LCJ Product Code

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 →