Luminance Red Cold Sore Device (TN1927G)

The Luminance Red Cold Sore Device is a handheld light-based treatment for herpes simplex labialis lesions on and around the lips. It uses LEDs to emit therapeutic near-infrared light (1072 nm) and non-therapeutic visible red light to shorten healing time, defined as time to patient-described re-epithelialization. The device is powered by a lithium-ion battery and is suitable for users with Fitzpatrick skin types I-IV.

The subject device differs from the predicate in three minor ways: (1) different materials of manufacture with confirmed biological safety for intended use, (2) increased battery capacity to allow more use between charges with completed battery testing, and (3) inclusion of a non-therapeutic visible red guidelight to enhance usability. The therapeutic wavelength and fundamental operating mechanism remain identical to the predicate.

IEC 62471 (photobiological safety), IEC 60601-1 and IEC 60601-1-2 and IEC 60601-1-11 (electrical safety and electromagnetic compatibility), IEC 60601-2-57 (non-laser light source equipment), IEC 62304 (software lifecycle), ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23 (biocompatibility and skin irritation/sensitization), and IEC 62366-1 (usability engineering).

The subject device uses identical therapeutic technology and has the same indications for use as the predicate (K222205). Material changes were biocompatibility-tested and raised no safety concerns. Battery capacity increase and the addition of a non-therapeutic guidelight are minor modifications that do not alter the fundamental safety or effectiveness profile. All verification and validation testing passed acceptance criteria, demonstrating comparable or superior performance to the predicate device.