# K050165: Modification to Ifl Professional System, Model C100

- Pathway: 510(k) (Traditional)
- Applicant: Cyden Limited
- Decided: Apr 19, 2005 after 84 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: 3 generations back to K000811 (2000). 5 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K024189: Nlite System, Model#: A00-1025/A00-1033, Icn Photonics, Ltd. (2003) Summary page 1.

## Most influential descendants
- K060234: Mccue Energist Ultra VPL Intense Pulse Light System (2006), 8 descendants of its own
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own

## 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 and the treatment of benign pigmented lesions. The IFL Professional is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K050165
Methodology: https://510kreport.com/methodology