# K030423: Powerlite 600 EP System

- Pathway: 510(k) (Traditional)
- Applicant: Preswede AB
- Decided: May 9, 2003 after 88 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: 2 generations back to K892514 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963249: Epilight Hair Removal System, Esc Medical Systems, Ltd. (1997) Summary page 1.

## Most influential descendants
- K033933: Powerlite 600 EX System (2004), 0 descendants of its own

## Indications for use
The Powerlite 600@ EP System is used for the removal of unwanted hair.

Source page: https://510kreport.com/device/K030423
Methodology: https://510kreport.com/methodology