Sun Pharmaceutical Industries has received approval from the US FDA for a new medical device to treat actinic keratoses (AK), a skin condition caused by long-term sun exposure. AK often appears as red, rough patches on sun-exposed areas and, if untreated, can develop into skin cancer.
The newly approved device is an upgraded version of the BLU-U Blue Light Photodynamic Therapy system. Unlike its older version, which used fluorescent tubes, the new model uses advanced LED technology, making it more compact and easier to operate.
The device is used in combination with LEVULAN® KERASTICK®, a topical solution containing aminolevulinic acid, for treating mild to moderate AK on the face, scalp, or arms.
Sun Pharma said the approval came through the USFDA’s Real-Time Review Program, underscoring the strength of its submission. The company believes the new LED BLU-U device will enhance both user experience and treatment outcomes.
