# K033933: Powerlite 600 EX System

- Pathway: 510(k) (Traditional)
- Applicant: Preswede AB
- Decided: Mar 16, 2004 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: 7 generations back to K910422 (1992). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030423: Powerlite 600 EP System, Preswede AB (2003) Summary page 1.
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems, Lumenis (2003) Summary page 1.

## Indications for use
An intense pulsed light, the Powerlite 6000 EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: * The treatment of tattoos; * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * The treatment of cutaneous lesions including warts, scars and striae; * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; * The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V.

Source page: https://510kreport.com/device/K033933
Methodology: https://510kreport.com/methodology