(340 days)
The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical structure equipped with artificial light sources using ultraviolet light technology, which produces ultraviolet radiation within the UVA and UVB ranges. The UV light is intended to induce skin tanning. The user stands within the unit.
This document is a 510(k) Premarket Notification from the FDA for a tanning booth device. It outlines the device's classification, indications for use, and a comparison to a predicate device.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of typical medical device performance evaluation (e.g., diagnostic accuracy, clinical efficacy). Instead, it focuses on the substantial equivalence of an "i8 Tanning Booth" to a predicate device, primarily based on:
- Technological characteristics: Number of lamps, wattage, maximum exposure time.
- Non-clinical performance data: Electrical and mechanical safety testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), and software development (IEC 62304).
These are engineering and safety standards, not clinical performance metrics or studies involving patient data/diagnoses that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human reader improvement.
Therefore, I cannot provide the requested information from the given text as it does not exist within the document for this specific device.
If this were a typical AI/ML medical device submission document, it would include sections detailing clinical study design, performance metrics, and results. This document is for a Class II medical device product code LEJ (Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products), which generally follows a different regulatory pathway focused on safety and functional equivalence rather than clinical diagnostic performance.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.