FDA Approves New Blue Light Tool for Actinic Keratosis

The US Food and Drug Administration (FDA) has granted premarket approval application (PMA) approval for BLU-U Blue Light Photodynamic Therapy (PDT) Illuminators, which feature light-emitting diode (LED) light panels instead of the fluorescent tubes used in previous models.1

Announced on May 16, 2025, by Sun Pharma, this new model (LED BLU-U), used in combination with aminolevulinic acid HCl (KERASTICK) topical solution, 20%, is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, and upper extremities.1

“We are pleased to receive the FDA’s approval of LED BLU-U and look forward to seeing the positive impact this next-generation device will have for those living with actinic keratosis,” said Abhay Gandhi, chief executive officer of Sun Pharma North America.

Actinic keratosis is a prominent, chronic skin condition, manifesting as rough, dry, and scaly patches because of sun overexposure. Spots vary in size and are commonly found on areas such as the face, scalp, arms, and hands. In some circumstances, actinic keratosis can lead to skin cancer, namely squamous cell carcinoma. Actinic keratosis is also notoriously difficult to identify and diagnose, as it exhibits high clinical variability. Additionally, many commonly used assessments are subjective in nature.2

LEDs have been widely used in treating actinic keratosis and other dermatological diseases, including psoriasis, wound healing, mild-to-moderate acne vulgaris, and actinic keratosis.3

The new model is approved for the same indications as its predecessor while taking up less space in a dermatologist’s office, and features a five-panel shape, improved LED arrangement, and lighter weight, all of which may increase patient comfort and ease of use.1

“As a company committed to innovation, we are confident that this new LED BLU-U model will provide improved efficiency and reliability while maintaining the safety and efficacy that healthcare professionals and people with Aks have come to trust from Sun Pharma," Gandhi added.1

The FDA approval was granted under the Real-Time Review Program, which reflects the robustness of the submission and Sun Pharma’s continued collaboration. Sun Pharma has indicated that the LED BLU-U will be available for delivery shortly.1

References

1. Sun Pharma Announces FDA Approval of Next Generation BLU-U Blue Light Photodynamic Therapy Illuminator for Actinic Keratosis. Sun Pharma. 16 May 2025. Accessed 19 May 2025. https://www.prnewswire.com/news-releases/sun-pharma-announces-fda-approval-of-next-generation-blu-u-blue-light-photodynamic-therapy-illuminator-for-actinic-keratosis-302457770.html

2. Burstein SE, Maibach H. Actinic keratosis metrics. Arch Dermatol Res. 2024;316(8):543. Published 2024 Aug 20. doi:10.1007/s00403-024-03305-5

3. Ablon G. Phototherapy with Light Emitting Diodes: Treating a Broad Range of Medical and Aesthetic Conditions in Dermatology. J Clin Aesthet Dermatol. 2018;11(2):21-27.