# K032191: Omnilight Fluorescent Pulsed Light System

- Pathway: 510(k) (Special)
- Applicant: Luxsano AB
- Decided: Aug 20, 2003 after 34 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: 6 generations back to K910422 (1992). 23 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos, Medical Bio Care Sweden AB (2002) Summary page 1.
- K022569: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular Lesions, Medical Bio Care Sweden AB (2002) Summary page 1.
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair, Medical Bio Care Sweden AB (2002) Summary page 1.
- K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction), Medical Bio Care Sweden AB (2002)

## Most influential descendants
- K081219: Apollo Mini Ipl System (2008), 3 descendants of its own
- K073477: Photonova Family of Pulsed Light Systems (2008), 3 descendants of its own
- K110304: Apex ER. Yag / Ipl System (2011), 2 descendants of its own
- K092734: E-Light Line (2010), 2 descendants of its own
- K124064: Young Again (2013), 1 descendant of its own

## Indications for use
The OmniLight FPL System is intended to be used in the following procedures: 1. Hair Removal in all Skin types according to the Fitzpatrick Scale 2. Permanent Hair reduction 3. Treatment of Vascular Lesions 4. Treatment of Pigmented Lesion 5. Tattoo Removal

Source page: https://510kreport.com/device/K032191
Methodology: https://510kreport.com/methodology