# K040156: Ifl Professional System, Model C100

- Pathway: 510(k) (Traditional)
- Applicant: Cyden Limited
- Decided: Mar 24, 2004 after 61 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). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems, Lumenis, Ltd. (2003) Summary page 1.

## Indications for use
The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction. In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; and the treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K040156
Methodology: https://510kreport.com/methodology