Sun Pharma’s LED Blue Light Therapy Device Gets FDA Pre-Market Approval

By BasisPoint Insight

May 19, 2025 at 9:29 AM IST

Sun Pharmaceutical Industries Ltd. on Friday announced that the US Food and Drug Administration has granted pre-market approval for its new blue light therapy illuminator device using LED technology, called LED BLU-U. This latest model will replace the earlier versions that used fluorescent tubes, the company said in a release.

The LED BLU-U is approved for the same uses as the previous model. It is designed to be used alongside Levulan and Kerastick topical solutions to treat actinic keratosis on the face, scalp, and upper limbs.

The approval came under the FDA’s Real-Time Review Program, and Sun Pharma said the product will soon be available in the market.