# K093465: Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Eclipsemed Global, Inc.
- Decided: Jan 5, 2010 after 60 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 15 generations back to K943450 (1995). 239 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060448: Lumenis One Family of Systems; Lumenis One., Lumenis, Ltd. (2006) Summary page 1.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 1.

## Indications for use
The 500 - l200nm intense pulsed light wavelengths are indicated for: * The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) * The treatment of cutaneous lesions, including warts, scars and striae The 560 - l200nm intense pulsed light wavelengths are indicated for: * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodlerma of Civatte, leg veins and venous malformations The 600 - 1200nm intense pulsed light wavelengths are indicated for: * The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The 400 - i200nm intense pulsed light wavelengths are indicated for: * The treatment of moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K093465
Methodology: https://510kreport.com/methodology