AlloX2 Pro Tissue Expanders

FDA 510(k) K214124 · Sientra, Inc.

Substantially Equivalent

510(k) numberK214124

Submission

Device name
AlloX2 Pro Tissue Expanders
Applicant
Sientra, Inc.
Santa Barbara, CA, US
Received
December 30, 2021
Decision date
June 8, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCJ – Tissue Expander And Accessories
Device class
Unclassified
Implant
Yes

Other 510(k)s with product code LCJ

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K254126Natrelle 133S Tissue ExpandersLCJ · Special AbbVie01/16/2026SE
K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsLCJ · Traditional Mentor Worldwide, LLC04/24/2025SE
K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderLCJ · Special Mentor Worldwide, LLC01/12/2025SE
K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderLCJ · Special Mentor Worldwide, LLC08/02/2024SE
K211676Motiva Flora SmoothSilk Tissue ExpanderLCJ · Traditional Motiva USA, LLC10/13/2023SE
K221127Sientra, inc. PortfinderLCJ · Traditional Sientra, Inc.05/10/2023SE
K180826Natrelle 133 Plus MICROCELL Tissue ExpanderLCJ · Traditional Allergan12/21/2018SE
K182335CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special Mentor Worldwide, LLC09/25/2018SE
K182054Natrelle 133S Tissue ExpanderLCJ · Special Allergan08/29/2018SE
K161483Unger Quad InjectorLCJ · Traditional Stradis Healthcare10/31/2016SE

More from Stradis Healthcare

510(k)DeviceDecision
K221127Sientra, inc. PortfinderLCJ · Traditional 05/10/2023SE
K200706Sientra OPUS Silicone Gel Breast Implant SizerMRD · Traditional 11/16/2020SE

Questions and answers

When was AlloX2 Pro Tissue Expanders cleared by the FDA?

AlloX2 Pro Tissue Expanders (K214124) received a 510(k) decision of Substantially Equivalent on June 8, 2023, 525 days after the submission was received.

What is the product code of K214124?

The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.