FDA 510(k) Applications for Medical Device Product Code "LCJ"
(Expander, Skin, Inflatable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K180826 | Allergan | Natrelle 133 Plus MICROCELL Tissue Expander | 12/21/2018 |
| K182054 | Allergan | Natrelle 133S Tissue Expander | 08/29/2018 |
| K102806 | ALLERGAN MEDICAL | NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS | 01/05/2011 |
| K143354 | ALLERGAN, INC. | Natrelle 133 Plus Tissue Expander | 08/20/2015 |
| K983385 | HUTCHISON INTL., INC. | HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS | 03/15/1999 |
| K112534 | LIFECELL CORP. | LIFECELL TISSUE EXPANDER | 08/10/2012 |
| K131692 | MARZ MEDICAL, INC | BLOSSOM SALINE DELIVERY ASSIST DEVICE | 07/10/2014 |
| K011500 | MENTOR CORP. | MENTOR CONTOUR PROFILE TISSUE EXPANDER | 12/03/2001 |
| K130813 | MENTOR CORP. | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | 04/11/2013 |
| K963066 | MENTOR CORP. | MENTOR INJECTION PORT DETECTOR (IPD) | 09/27/1996 |
| K150777 | MENTOR WORLDWIDE LLC | Artoura Breast Tissue Expander | 04/24/2015 |
| K161176 | MENTOR WORLDWIDE LLC | ARTOURA Breast Tissue Expanders with Smooth Surface | 05/23/2016 |
| K152496 | MENTOR WORLDWIDE LLC | CPX 4 Breast Tissue Expander | 02/19/2016 |
| K182335 | Mentor Worldwide LLC | CPX 4 Breast Tissue Expander with Smooth Surface | 09/25/2018 |
| K142998 | MENTOR WORLDWIDE LLC | CPX Control Breast Tissue Expander | 12/19/2014 |
| K243836 | Mentor Worldwide LLC | MentorÖ CPX Ö 4 PLUS Enhance Breast Tissue Expander | 01/12/2025 |
| K241918 | Mentor Worldwide LLC | MENTORÖ CPXÖ4 PLUS Enhance Breast Tissue Expander | 08/02/2024 |
| K242963 | Mentor Worldwide LLC | MENTORÖ PliaFormÖ Breast Tissue Expander w/ Suture Tabs | 04/24/2025 |
| K211676 | Motiva USA LLC | Motiva Flora SmoothSilk Tissue Expander | 10/13/2023 |
| K983792 | SEARE BIOMEDICAL CORP. | SEARE BIOMEDICAL SILICONE TISSUE EXPANDER | 12/11/1998 |
| K214124 | Sientra, Inc. | AlloX2 Pro Tissue Expanders | 06/08/2023 |
| K221127 | Sientra, Inc. | Sientra, inc. Portfinder | 05/10/2023 |
| K981852 | SILIMED, LLC. | SILIMED TISSUE EXPANDER | 08/05/1998 |
| K070303 | SPECIALTY SURGICAL PRODUCTS | SILICONE TISSUE EXPANDER | 06/22/2007 |
| K140383 | SPECIALTY SURGICAL PRODUCTS, INC. | ALLOX2 TISSUE EXPANDERS | 10/28/2014 |
| K982067 | SPECIALTY SURGICAL PRODUCTS, INC. | MAGNETIC PORT SILICONE TISSUE EXPANDER | 07/13/1998 |
| K974209 | SPECIALTY SURGICAL PRODUCTS, INC. | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | 02/06/1998 |
| K161483 | STRADIS HEALTHCARE | Unger Quad Injector | 10/31/2016 |
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