# K182453: ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

- Pathway: 510(k) (Abbreviated)
- Applicant: I-Tech Industries Srl
- Decided: Jan 11, 2019 after 126 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 56 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053611: Smoothshapes, Bicellulase, Inc. (2006) Summary page 4.
- K061603: Smoothshapes, Biocellulase, Inc. (2006) Summary page 4.

## Most influential descendants
- K211272: ICOONE Laser Med (also referred to as ICOONE Medical laser) (2021), 1 descendant of its own
- K231092: T-Shape 2 (2023), 0 descendants of its own

## Indications for use
ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K182453
Methodology: https://510kreport.com/methodology