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510(k) K182453

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) by I-Tech Industries Srl — Product Code NUV

K182453 is an FDA 510(k) premarket notification submitted by I-Tech Industries Srl for the device "ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)". The FDA issued a decision of Substantially Equivalent on January 11, 2019. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. I-Tech Industries Srl has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
September 7, 2018
Clearance Type
Abbreviated
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 I-Tech Industries Srl

  • K211272 — ICOONE Laser Med (also referred to as ICOONE Medical laser) (June 22, 2021)
  • K875319 — NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS (January 22, 1988)
  • K874634 — NSN #6515-00-333-2400 ADSON DRESSING FORCEPS (December 2, 1987)

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)
  • 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)
  • K090221 — REACTION SYSTEM (July 1, 2009)

FDA data resources