# K200736: Stardust Med

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Group S.R.L.
- Decided: Jun 26, 2020 after 95 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 24 generations back to K943450 (1995). 533 ancestors in all.
No later device cites it as a predicate yet.
0 of 534 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191942: MT One Diamond, M&T S.R.L. (2019) Summary page 4.

## Indications for use
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery. STARDUST MED is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime

Source page: https://510kreport.com/device/K200736
Methodology: https://510kreport.com/methodology