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510(k) K050397

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2005
Date Received
February 16, 2005
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 Syneron Medical, Ltd.

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  • K151655 — CO2RE System (September 15, 2015)
  • K141507 — TWO SKIN TREATMENT SYSTEM (December 8, 2014)
  • K141708 — ULTRASHAPE SYSTEM (October 6, 2014)
  • K133238 — CONTOUR I V3.1 SYSTEM (April 10, 2014)
  • K120510 — TRANSCEND (July 19, 2013)

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  • K131362 — INMODE WMBODY DEVICE (October 8, 2013)
  • K122579 — VELASHAPE (September 13, 2012)
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  • 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)