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510(k) K070092

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

K070092 is an FDA 510(k) premarket notification submitted by Syneron Medical, Ltd. for the device "MODIFICATION TO VELASMOOTH, SHAPER". The FDA issued a decision of Substantially Equivalent on July 27, 2007. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Syneron Medical, Ltd. has at least 10 other 510(k) clearances on record.

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

Other clearances by Syneron Medical, Ltd.

  • K170370 — ULTRASHAPE POWER SYSTEM (May 15, 2017)
  • K163415 — SlimShape System (April 20, 2017)
  • K162163 — UltraShape System (November 17, 2016)
  • K161952 — UltraShape System (November 7, 2016)
  • K160896 — ULTRASHAPE POWER SYSTEM (July 8, 2016)
  • 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)

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)
  • 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)

FDA data resources