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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.

The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 530 to 1200nm wavelength range. The system consists of a base unit containing the electrical and electronic control subsystems, an umbilical interconnection between the base unit and the handpiece, and the handpiece which houses the xenon light source, filter and finger switch.

I'm sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary statement for the "IFL Professional System" and primarily focuses on establishing substantial equivalence to predicate devices based on identical technological characteristics and intended indications for use.

It explicitly states: "Not Applicable. Substantial equivalence to the predicate devices is claimed for identical technological characteristics and intended Indications for Use." This indicates that the approval was based on demonstrating similarity to already approved devices, rather than on presenting new performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested information.

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