# K090525: Loi System

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Jun 1, 2009 after 95 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). 170 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072459: Omnilux New-U, Photo Therapeutics, Inc. (2008) Summary page 1.
- K062991: Gentlewaves Consumer Led Photomodulation Device, Light Bioscience, LLC (2008) Summary page 1.
- K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System), Reliant Technologies, Inc. (2007) Summary page 2.

## 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
- K163137: NIRA Beauty Skin Laser (2017), 1 descendant of its own
- K130459: Tria Fan System (2013), 1 descendant of its own

## Indications for use
The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K090525
Methodology: https://510kreport.com/methodology