# K110349: Clear+Brilliant Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Solta Medical, Inc.
- Decided: May 3, 2011 after 85 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). 129 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063808: Fraxel IV SR Laser System, Reliant Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- K111840: Emerge Fractional Laser (2011), 3 descendants of its own
- K230077: LaserME (2023), 2 descendants of its own
- K234004: Medical diode laser systems (CHARISMA, REGAL) (2025), 1 descendant of its own
- K120433: Clear + Brilliant Laser System (2012), 1 descendant of its own
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own

## Indications for use
Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

Source page: https://510kreport.com/device/K110349
Methodology: https://510kreport.com/methodology