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510(k) K070092

MODIFICATION TO VELASMOOTH, SHAPER by Syneron Medical, Ltd. — Product Code NUV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2007
Date Received
January 10, 2007
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

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  • K141708 — ULTRASHAPE SYSTEM (October 6, 2014)
  • K133238 — CONTOUR I V3.1 SYSTEM (April 10, 2014)
  • K120510 — TRANSCEND (July 19, 2013)

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  • K161892 — Slimming Treatment Device (March 2, 2017)
  • K131362 — INMODE WMBODY DEVICE (October 8, 2013)
  • 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)