Medical Diode Laser Systems (THEIA808)

The THEIA808 is a medical diode laser system designed for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. It uses an 808nm wavelength diode laser that targets melanin in hair follicles to destroy their regenerative capacity, with dynamic cooling to protect the epidermis from thermal damage.

The device operates at 808nm wavelength with a 1.44 cm² spot size, fluence range of 5-120 J/cm², adjustable frequency of 1-10 Hz, and pulse duration of 22-570ms. It uses water cooling, includes software controls, and employs both aluminum alloy and sapphire in the handpiece. Key differences from the predicate (K162659) are the extended pulse duration range (22-570ms vs 5-400ms) and different dimensions/weight, but all core laser parameters remain equivalent.

The device was tested against IEC 60601-1:2005+A1:2012 (medical electrical equipment general safety), EN 60601-1-2:2015 (electromagnetic compatibility), EN 60601-2-22:2020 (surgical laser equipment), EN 60825-1:2014 (laser safety classification), and ISO 10993 standards for cytotoxicity, skin sensitization, and irritation.

The proposed device shares identical intended use, product code, regulatory classification, laser type, wavelength, spot size, fluence, irradiance, cooling method, and material biocompatibility with the predicate device K162659. The differences in pulse duration range, physical dimensions, and weight do not introduce new safety or effectiveness concerns and remain within acceptable operational parameters. Non-clinical testing demonstrates equivalent performance and compliance with the same safety standards as the predicate device.