Natrelle 133 Plus MICROCELL Tissue Expander
FDA 510(k) K180826 · Allergan
510(k) numberK180826
Submission
- Device name
- Natrelle 133 Plus MICROCELL Tissue Expander
- Applicant
- Allergan
Irvine, CA, US - Received
- March 30, 2018
- Decision date
- December 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LCJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254126 | Natrelle 133S Tissue ExpandersLCJ · Special | AbbVie | 01/16/2026SE |
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture TabsLCJ · Traditional | Mentor Worldwide, LLC | 04/24/2025SE |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 01/12/2025SE |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 08/02/2024SE |
| K211676 | Motiva Flora SmoothSilk Tissue ExpanderLCJ · Traditional | Motiva USA, LLC | 10/13/2023SE |
| K214124 | AlloX2 Pro Tissue ExpandersLCJ · Traditional | Sientra, Inc. | 06/08/2023SE |
| K221127 | Sientra, inc. PortfinderLCJ · Traditional | Sientra, Inc. | 05/10/2023SE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special | Mentor Worldwide, LLC | 09/25/2018SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | Allergan | 08/29/2018SE |
| K161483 | Unger Quad InjectorLCJ · Traditional | Stradis Healthcare | 10/31/2016SE |
More from Stradis Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel ImplantsMRD · Special | 06/02/2021SE |
| K193589 | TrueTear Intranasal Tear NeurostimulatorQBR · Traditional | 08/31/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | 08/08/2019SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | 08/29/2018SE |
| K161457 | XEN Glaucoma Treatment SystemKYF · Traditional | 11/21/2016SE |
| K143354 | Natrelle 133 Plus Tissue ExpanderLCJ · Traditional | 08/20/2015SE |
| K123128 | Seri Surgical ScaffoldOXF · Traditional | 04/25/2013SE |
| K083812 | Refresh Optive Lens Comfort Rewetting DropsLPN · Traditional | 07/09/2009SE |
| K051852 | Single Amplifier for BotoxGWL · Traditional | 09/14/2005SE |
| K014202 | Complete Brand Multi-Purpose SolutionLPN · Traditional | 02/20/2002SE |
Questions and answers
When was Natrelle 133 Plus MICROCELL Tissue Expander cleared by the FDA?
Natrelle 133 Plus MICROCELL Tissue Expander (K180826) received a 510(k) decision of Substantially Equivalent on December 21, 2018, 266 days after the submission was received.
What is the product code of K180826?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.