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510(k) K161892

Slimming Treatment Device by Beijing Honkon Technologies Co., Ltd. — Product Code NUV

K161892 is an FDA 510(k) premarket notification submitted by Beijing Honkon Technologies Co., Ltd. for the device "Slimming Treatment Device". The FDA issued a decision of Substantially Equivalent on March 2, 2017. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Beijing Honkon Technologies Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2017
Date Received
July 11, 2016
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 Beijing Honkon Technologies Co., Ltd.

  • K131838 — DIODE LASER FOR HIAR REMOVAL (April 24, 2014)
  • K131837 — CO2 FRACTIONAL LASER (January 22, 2014)
  • K131857 — Q-SWITCHED ND:YAG LASER (January 16, 2014)
  • K131859 — MULTIFUNCTIONAL SERIES (October 18, 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)
  • 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)
  • K090221 — REACTION SYSTEM (July 1, 2009)

FDA data resources