# K013366: Prolite Pulsed Light System for the Removal of Unwanted Hair

- Pathway: 510(k) (Traditional)
- Applicant: Medical Bio Care Sweden AB
- Decided: Jan 8, 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: 4 generations back to K910422 (1992). 11 ancestors in all.
1,129 later devices descend from it; 3 cite it directly.
0 of 1,141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974536: Photoderm HR System, Esc Medical Systems, Ltd. (1998) Summary page 1.

## Most influential descendants
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair (2002), 1,127 descendants of its own
- 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

## 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/K013366
Methodology: https://510kreport.com/methodology