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510(k) K101366

I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) by Chromogenex Technologies, Ltd. — Product Code NUV

K101366 is an FDA 510(k) premarket notification submitted by Chromogenex Technologies, Ltd. for the device "I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)". The FDA issued a decision of Substantially Equivalent on September 17, 2010. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2010
Date Received
May 17, 2010
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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  • 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)
  • 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