Home / 510(k) Clearances / K143354

510(k) K143354

Natrelle 133 Plus Tissue Expander by Allergan, Inc. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2015
Date Received
November 24, 2014
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 Allergan, Inc.

  • K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants (June 2, 2021)
  • K193589 — TrueTear Intranasal Tear Neurostimulator (August 31, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)
  • K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS (July 9, 2009)
  • K051852 — SINGLE AMPLIFIER FOR BOTOX (September 14, 2005)

Other clearances for product code LCJ

  • K254126 — Natrelle 133S Tissue Expanders (January 16, 2026)
  • 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)
  • K214124 — AlloX2 Pro Tissue Expanders (June 8, 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)