# K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair

- Pathway: 510(k) (Special)
- Applicant: Medical Bio Care Sweden AB
- Decided: Aug 29, 2002 after 27 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). 12 ancestors in all.
1,127 later devices descend from it; 4 cite it directly.
0 of 1,140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013366: Prolite Pulsed Light System for the Removal of Unwanted Hair, Medical Bio Care Sweden AB (2002) Summary page 1.

## Most influential descendants
- K023954: Altus Medical Coolglide Laser Systems and Accessories (2003), 1,117 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K032460: Profile BBL System (2003), 569 descendants of its own

## Indications for use
The ProLite Pulsed Light System is intended to remove unwanted hair for all skin types according to the Fitzpatrick Scale.

Source page: https://510kreport.com/device/K022568
Methodology: https://510kreport.com/methodology