LCJ

FDA Product Code LCJ: Tissue Expander And Accessories

Leading manufacturers include Mentor Corp., Mentor Worldwide, LLC and Specialty Surgical Products, Inc..

55
Total
55
Cleared
142d
Avg days
1977
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 90d recently vs 145d 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
Cleared Oct 31, 2016
Unger Quad Injector
K161483
Stradis Healthcare
General & Plastic Surgery · 153d
Cleared May 23, 2016
ARTOURA Breast Tissue Expanders with Smooth Surface
K161176
Mentor Worldwide, LLC
General & Plastic Surgery · 27d
Cleared Feb 19, 2016
CPX 4 Breast Tissue Expander
K152496
Mentor Worldwide, LLC
General & Plastic Surgery · 171d
Cleared Aug 20, 2015
Natrelle 133 Plus Tissue Expander
K143354
Allergan, Inc.
General & Plastic Surgery · 269d
Cleared Apr 24, 2015
Artoura Breast Tissue Expander
K150777
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared Dec 19, 2014
CPX Control Breast Tissue Expander
K142998
Mentor Worldwide, LLC
General & Plastic Surgery · 63d
Cleared Oct 28, 2014
ALLOX2 TISSUE EXPANDERS
K140383
Specialty Surgical Products, Inc.
General & Plastic Surgery · 256d
Cleared Jul 10, 2014
BLOSSOM SALINE DELIVERY ASSIST DEVICE
K131692
Marz Medical, Inc.
General & Plastic Surgery · 395d
Cleared Apr 11, 2013
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813
Mentor Corp.
General & Plastic Surgery · 17d
Cleared Aug 10, 2012
LIFECELL TISSUE EXPANDER
K112534
Lifecell Corp.
General & Plastic Surgery · 344d
Cleared Jan 05, 2011
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
K102806
Allergan Medical
General & Plastic Surgery · 99d
Cleared Jun 22, 2007
SILICONE TISSUE EXPANDER
K070303
Specialty Surgical Products
General & Plastic Surgery · 142d
Cleared Dec 03, 2001
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500
Mentor Corp.
General & Plastic Surgery · 201d
Cleared Mar 15, 1999
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K983385
Hutchison Intl., Inc.
General & Plastic Surgery · 171d

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 declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - LCJ Product Code

Recent submissions under LCJ have taken an average of 90 days to reach a decision - down from 145 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 →