# K111840: Emerge Fractional Laser

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Nov 14, 2011 after 138 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: 17 generations back to K910422 (1992). 295 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103664: Primus Aesthetic Platform, Palomar Medical Technologies, Inc. (2011) Summary page 1.
- K090525: Loi System, Palomar Medical Products, Inc. (2009) Summary page 1.
- K063808: Fraxel IV SR Laser System, Reliant Technologies, Inc. (2007) Summary page 1.
- K110349: Clear+Brilliant Laser System, Solta Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K230077: LaserME (2023), 2 descendants of its own
- K234004: Medical diode laser systems (CHARISMA, REGAL) (2025), 1 descendant of its own
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own

## Indications for use
The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to Ieniigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Source page: https://510kreport.com/device/K111840
Methodology: https://510kreport.com/methodology