Klär Lite (RCW-KL1000)

The Klär Lite (RCW-KL1000) is a narrowband UV-B light-emitting phototherapy device intended for localized treatment of dermatologic conditions including psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types. It is a prescription-only, handheld home-use device with an integrated diffuser and microcontroller-based dose control.

The device uses narrowband UV-B LED array technology with a nominal peak wavelength of 311 ± 2 nm (within the 295-320 nm UV-B range), output irradiance of 3.0-5.0 mW/cm², treatment area of 5.08 cm × 5.08 cm, and software-controlled preset and manual operating modes with real-time temperature feedback. It includes an optical filter and integrated thermal sensor with auto-shutdown safety features, powered by medical-grade DC supply.

Testing conducted per IEC 60601-1:2012 (electrical safety), IEC 60601-1-11:2015 (home-use requirements), IEC 60601-1-2:2014 (EMC), IEC 62471:2006 (photobiological safety), ISO 15004-2 (optical radiation), ISO 10993 series (biocompatibility), IEC 62304:2006 (software lifecycle), ISO 14971:2019 (risk management), and IEC 62366-1:2015 (usability).

The Klär Lite is substantially equivalent to the predicate Clarify Medical Phototherapy System (K170489) because both use identical narrowband UV-B LED technology with comparable wavelengths, light sources, and safety features. Output irradiance falls within the predicate's range, and the subject device incorporates equivalent or enhanced features including temperature-compensated dose control and validated cleaning methods, with identical prescription status and conformance to the same consensus standards.