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510(k) K211272

ICOONE Laser Med (also referred to as ICOONE Medical laser) by I-Tech Industries Srl — Product Code NUV

K211272 is an FDA 510(k) premarket notification submitted by I-Tech Industries Srl for the device "ICOONE Laser Med (also referred to as ICOONE Medical laser)". The FDA issued a decision of Substantially Equivalent on June 22, 2021. 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
June 22, 2021
Date Received
April 27, 2021
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 I-Tech Industries Srl

  • K182453 — ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (January 11, 2019)
  • 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)
  • 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)
  • K090221 — REACTION SYSTEM (July 1, 2009)

FDA data resources