IFL Professional System, Model C100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050165 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IFL Professional System, Model C100, is a pulsed Xenon flashlamp device classified as a Powered Laser Surgical Instrument. It delivers energy within a specific nanometer wavelength range and comprises a base unit with electronic control subsystems, an umbilical cable, and a handpiece containing the light source, filter, and finger switch. This system is designed for use in dermatological and plastic surgery procedures, providing controlled energy output for surgical applications.
The device is operated by clinicians in surgical settings and is supplied as a reusable system. It is not described as sterile or single-use in the provided data. The IFL Professional System, Model C100, holds an FDA 510(k) clearance under the classification GEX, which pertains to powered laser surgical instruments across multiple specialties. The modification submission (K050165) was filed by Cyden Limited, Swansea, Wales, and is classified under the Special Controls for Class II devices.
Frequently asked questions
What is the IFL Professional System, Model C100 used for?
The IFL Professional System, Model C100 is a powered laser surgical instrument designed specifically for dermatological and plastic surgery procedures. It delivers controlled energy output within a defined wavelength range, enabling clinicians to perform precise surgical interventions in these specialties. The device’s pulsed Xenon flashlamp technology allows for targeted tissue effects, making it suitable for procedures requiring controlled energy delivery.
How is the IFL Professional System, Model C100 supplied and intended for use?
The IFL Professional System, Model C100 is supplied as a reusable system, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. It consists of a base unit with electronic controls, an umbilical cable, and a handpiece containing the light source, filter, and finger switch. This design ensures durability and reliability for surgical applications in dermatology and plastic surgery.
Is the IFL Professional System, Model C100 sterile or single-use?
The IFL Professional System, Model C100 is not described as a sterile or single-use device. As a reusable system, it must be cleaned and maintained according to manufacturer guidelines to ensure safe and effective use in surgical environments. Sterility is not a feature of this device, and it is intended for repeated clinical applications.
What regulatory clearance does the IFL Professional System, Model C100 hold?
The IFL Professional System, Model C100 holds an FDA 510(k) clearance under the product code GEX, which categorizes it as a powered laser surgical instrument. The clearance was granted as substantially equivalent to a predicate device, following a traditional review process. This classification applies to devices used across multiple surgical specialties, including dermatology and plastic surgery.
What components make up the IFL Professional System, Model C100?
The system comprises three main components: a base unit containing electronic control subsystems, an umbilical cable connecting the base unit to the handpiece, and the handpiece itself, which houses the pulsed Xenon flashlamp, filter, and finger switch. This modular design allows clinicians to operate the device with precision, directing energy output where needed during surgical procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modification to Ifl Professional System, Model C100, Modification to Ifl Professional System, Model C100, K040156 FDA 510 (k) - IFL PROFESSIONAL SYSTEM | Cyden Limited, PDF K050165 - Modification to Ifl Professional System, Model C100
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050165 | Class II | Active |
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Manufacturer
- Manufacturer
- Cyden Limited
Sources (1)
- FDA 510(k) K050165 24 fields · synced Oct 1, 2026