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KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.

KBL Sunlamp Hybrid Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources using the hybrid light technology. The hybrid light technology produces ultraviolet radiation and radiation in the visual range of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The user is lying on a bench.

The provided document is a 510(k) Pre-market Notification for KBL GmbH sunlamp products, specifically the KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, and KBL 8000 alpha hybridSun. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a novel AI/software medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically found in the context of validating performance for diagnostic or therapeutic AI/software, is not present in this document.

This document details the following for sunlamp products:

1. Device Type: Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
2. Regulation Number: 21 CFR 878.4635
3. Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products
4. Regulatory Class: Class II
5. Product Code: LEJ
6. Indications for Use: "KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person." This is identical to the predicate device.
7. Comparison to Predicate: The document largely focuses on comparing the technological characteristics (number of lamps, wattage, dimensions, etc.) of the proposed devices to predicate devices (KBL 6800 alpha and KBL 7900 alpha). The evaluation states that differences are "Equivalent" or "Identical" and do not impact functionality or safety.
8. Performance Data: Non-clinical performance tests were conducted to ensure compliance with relevant standards for sunlamp products, including:
   • Biocompatibility testing (DIN EN ISO 10993 series)
   • Electrical and mechanical safety testing (IEC 60601-1, IEC 60335-1, UL482)
   • Electromagnetic compatibility testing (IEC 60601-1-2)
   • Spectral emission measurement (IEC 60335-2-27)
   • Software verification and validation (FDA Guidance for Software in Medical Devices)
   • Performance Standards testing (21 CFR 1040.20)
   • Irradiance ratio limits (21 CFR 1040.20(c)(1))
   • Maximum timer intervals and exposure schedules (FDA policy)

Key takeaway: This 510(k) submission is for physical sunlamp devices, not an AI/software medical device. The "performance data" refers to compliance with safety and electrical standards for sunlamps, not the type of diagnostic performance (e.g., sensitivity, specificity) that requires the detailed study design elements you asked for. Therefore, I cannot extract the requested information from this document.

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