# K191942: MT One Diamond

- Pathway: 510(k) (Traditional)
- Applicant: M&T S.R.L.
- Decided: Oct 17, 2019 after 87 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: 23 generations back to K943450 (1995). 532 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 534 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152714: Quanta Forte, Quanta System Spa (2015) Summary page 4.
- K172413: MT ONE, M&T S.R.L. (2017) Summary page 4.

## Most influential descendants
- K200736: Stardust Med (2020), 0 descendants of its own

## Indications for use
MT ONE DIAMOND AND ITS HANDPIECE 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. MT ONE DIAMOND WITH HR808 NM LASER HANDPIECE 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/K191942
Methodology: https://510kreport.com/methodology