

# LCJ · Tissue Expander And Accessories

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LCJ

## Overview

- **Product Code:** LCJ
- **Device Name:** Tissue Expander And Accessories
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (20 of 55)

Showing 20 most recent of 55 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254126](/device/K254126.md) | Natrelle 133S Tissue Expanders | AbbVie | Jan 16, 2026 | SESE |
| [K242963](/device/K242963.md) | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | Apr 24, 2025 | SESE |
| [K243836](/device/K243836.md) | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | Jan 12, 2025 | SESE |
| [K241918](/device/K241918.md) | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | Aug 2, 2024 | SESE |
| [K211676](/device/K211676.md) | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | Oct 13, 2023 | SESE |
| [K214124](/device/K214124.md) | AlloX2 Pro Tissue Expanders | Sientra, Inc. | Jun 8, 2023 | SESE |
| [K221127](/device/K221127.md) | Sientra, inc. Portfinder | Sientra, Inc. | May 10, 2023 | SESE |
| [K180826](/device/K180826.md) | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | Dec 21, 2018 | SESE |
| [K182335](/device/K182335.md) | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | Sep 25, 2018 | SESE |
| [K182054](/device/K182054.md) | Natrelle 133S Tissue Expander | Allergan | Aug 29, 2018 | SESE |
| [K161483](/device/K161483.md) | Unger Quad Injector | Stradis Healthcare | Oct 31, 2016 | SESE |
| [K161176](/device/K161176.md) | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | May 23, 2016 | SESE |
| [K152496](/device/K152496.md) | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | Feb 19, 2016 | SESE |
| [K143354](/device/K143354.md) | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | Aug 20, 2015 | SESE |
| [K150777](/device/K150777.md) | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | Apr 24, 2015 | SESE |
| [K142998](/device/K142998.md) | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | Dec 19, 2014 | SESE |
| [K140383](/device/K140383.md) | ALLOX2 TISSUE EXPANDERS | Specialty Surgical Products, Inc. | Oct 28, 2014 | SESE |
| [K131692](/device/K131692.md) | BLOSSOM SALINE DELIVERY ASSIST DEVICE | Marz Medical, Inc. | Jul 10, 2014 | SESE |
| [K130813](/device/K130813.md) | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | Mentor Corp. | Apr 11, 2013 | SESE |
| [K112534](/device/K112534.md) | LIFECELL TISSUE EXPANDER | Lifecell Corp. | Aug 10, 2012 | SESE |

## Top Applicants

- Mentor Corp. — 9 clearances
- Mentor Worldwide, LLC — 8 clearances
- Mcghan Medical Corp. — 7 clearances
- Specialty Surgical Products, Inc. — 3 clearances
- Allergan — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/LCJ](https://fda.innolitics.com/productcode/LCJ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
