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510(k) K090221

REACTION SYSTEM by Viora , Ltd. — Product Code NUV

K090221 is an FDA 510(k) premarket notification submitted by Viora , Ltd. for the device "REACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 1, 2009. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Viora , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2009
Date Received
January 30, 2009
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 Viora , Ltd.

  • K202247 — V30 system, V20 system, V10 system, V-VR Hand piece (December 9, 2020)
  • K201064 — V30 System, V20 System, V10 System, V-FR Handpiece (July 15, 2020)
  • K200468 — V30 system, V20 system, V10 system, V-FC Handpiece (May 21, 2020)
  • K162363 — V30 system, V-Form Handpiece BC Medium applicator (November 18, 2016)
  • K152611 — V20 system (February 19, 2016)
  • K150035 — V10 system (May 1, 2015)
  • K142093 — V20 SYSTEM (November 14, 2014)
  • K141904 — VIORA V-TOUCH (October 21, 2014)
  • K133837 — VIORA V-TOTAL (April 9, 2014)
  • K090399 — TRIOS SYSTEM (June 10, 2009)

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