Home / 510(k) Clearances / K131362

510(k) K131362

INMODE WMBODY DEVICE by Inmode MD , Ltd. — Product Code NUV

K131362 is an FDA 510(k) premarket notification submitted by Inmode MD , Ltd. for the device "INMODE WMBODY DEVICE". The FDA issued a decision of Substantially Equivalent on October 8, 2013. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Inmode MD , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2013
Date Received
May 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended to temporarily alter the appearance of cellulite

Other clearances by Inmode MD , Ltd.

  • K210492 — InMode RF Pro System (July 12, 2021)
  • K192695 — InMode System with the Morpheus8 (Fractora) Applicators (December 27, 2019)
  • K191855 — EmFace Device (October 29, 2019)
  • K183450 — EmBody System (June 20, 2019)
  • K182325 — InMode RF System (September 26, 2018)
  • K180719 — InMode Diolaze System (June 14, 2018)
  • K180189 — InMode System with Fractora3D/3D-90 Applicators (June 1, 2018)
  • K173677 — InMode VLaze (February 23, 2018)
  • K172302 — InMode PLUS System (December 8, 2017)
  • K171593 — InMode RF System (October 10, 2017)

Other clearances for product code NUV

  • K231092 — T-SHAPE 2 (September 22, 2023)
  • K211272 — ICOONE Laser Med (also referred to as ICOONE Medical laser) (June 22, 2021)
  • K182453 — ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (January 11, 2019)
  • K161892 — Slimming Treatment Device (March 2, 2017)
  • K122579 — VELASHAPE (September 13, 2012)
  • K101147 — MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (January 21, 2011)
  • K101366 — I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (September 17, 2010)
  • K100230 — SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V (April 2, 2010)
  • K092195 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (October 1, 2009)
  • K090221 — REACTION SYSTEM (July 1, 2009)

FDA data resources