# K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Bio Care Sweden AB
- Decided: Dec 16, 2002 after 90 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: 5 generations back to K910422 (1992). 17 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1.

## Most influential descendants
- K040659: Mccue PLC Energist Ultra Variable Pulsed Light System (2004), 11 descendants of its own
- K032191: Omnilight Fluorescent Pulsed Light System (2003), 9 descendants of its own
- K060234: Mccue Energist Ultra VPL Intense Pulse Light System (2006), 8 descendants of its own
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own

## Indications for use
The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.

Source page: https://510kreport.com/device/K023081
Methodology: https://510kreport.com/methodology