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510(k) K214124

AlloX2 Pro Tissue Expanders by Sientra, Inc. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2023
Date Received
December 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Sientra, Inc.

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  • K200706 — Sientra OPUS Silicone Gel Breast Implant Sizer (November 16, 2020)

Other clearances for product code LCJ

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  • K242963 — MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (April 24, 2025)
  • K243836 — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (January 12, 2025)
  • K241918 — MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (August 2, 2024)
  • K211676 — Motiva Flora SmoothSilk Tissue Expander (October 13, 2023)
  • K221127 — Sientra, inc. Portfinder (May 10, 2023)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182335 — CPX 4 Breast Tissue Expander with Smooth Surface (September 25, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • K161483 — Unger Quad Injector (October 31, 2016)