# K233550: MOSAIC 3D (Surgical Laser)

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Aesthetic
- Decided: Jan 2, 2024 after 60 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 12 generations back to K910422 (1992). 147 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080932: Mosaic Laser System, Lutronic Corporation (2008) Summary page 5.

## Indications for use
The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.

Source page: https://510kreport.com/device/K233550
Methodology: https://510kreport.com/methodology