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Zeno Acne Device
Zeno is a portable hand-held device that produces accurately controlled low level sustained heat for use in treating dermatological disorders, specifically, mild to moderate acne. Individual acne blemishes are treated for a preset time of 2 and 1/2 minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish. The device is powered by rechargeable AAA nickel-metal hydride batteries.
Indications for Use
Zeno is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
- Preclinical Testing
In vitro testing demonstrated significant sensitivity of p. acnes bacterial cells to the effects of sustained low-level heat.
Biocompatibility testing of the tip material was conducted in accordance with the ISO 10993 Biological Testing of Medical and Dental Materials and Devices and the tip material is considered biocompatible.
Zeno was tested for EMI in accordance with the IEC 60601-1 standard. Zeno operates within the EMI emission, susceptibility and static discharge levels specified in the IEC 6060 1-1 standard. - Clinical Testing
Clinical testing was conducted in both a controlled practitioner office environment and a consumer home use environment and submitted as part of the 510(k) application to confirm that Zeno is as safe and effective as the predicate device. The controlled clinical study design was a randomized, doubled-blinded study.
Substantial Equivalence
The Zeno and its predicate devices are all devices that use either light or heat to treat the dermatological condition of mild to moderate acne by exposing the surface of the skin to the light at precise wavelengths and temperatures or heat at precise temperatures. Although there are differences in the technological characteristics of the Zeno and its predicate devices, those differences do not raise new questions of safety or efficacy.
Another difference is Zeno will be available over the counter (OTC) versus the predicate device which is prescription use only however there are no new safety or efficacy concerns regarding this use as evidenced by the clinical testing that was conducted on Zeno. Thus, Zeno is substantially equivalent to the predicate device for treatment of mild to moderate acne.
Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use.
References:
Food and Drug Administration
July 2005
www.fda.gov