# K211272: ICOONE Laser Med (also referred to as ICOONE Medical laser)

- Pathway: 510(k) (Traditional)
- Applicant: I-Tech Industries Srl
- Decided: Jun 22, 2021 after 56 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: 15 generations back to K943450 (1995). 57 ancestors in all.
1 later device descends 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)
- K182453: ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER), I-Tech Industries Srl (2019) Summary page 5.

## Most influential descendants
- K231092: T-Shape 2 (2023), 0 descendants of its own

## Indications for use
ICOONE Laser med (also referred to as ICOONE Medical laser) 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/K211272
Methodology: https://510kreport.com/methodology