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# FDA De Novo for Dry Eye Device
- URL: https://www.fdaweb.com/fda-de-novo-for-dry-eye-device/
- Published: 2021-04-29T12:00:00.000Z
- Updated: 2026-09-14T16:56:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149221

FDA has granted Lumenis a de novo authorization for its newest intense pulsed light device (IPL) for improving signs of dry eye disease due to meibomian gland dysfunction. The common disorder causes dry, gritty, burning, tired eyes and fluctuating vision, according to the company. The authorization was based on data from a multi-center, double-blinded, randomized controlled trial that showed Lumenis IPL with optimal pulse technology significantly improved tear breakup time, meibum quality, and meibomian gland expressibility, Lumenis says.