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# Ultrasound Devices for Glaucoma Reclassified
- URL: https://www.fdaweb.com/ultrasound-devices-for-glaucoma-reclassified/
- Published: 2024-05-20T12:00:00.000Z
- Updated: 2026-09-14T14:31:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157015

*Federal Register* notice: FDA is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 device (product code LZR), into Class 2 (special controls), subject to premarket notification. The agency is also establishing special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. Such devices are identified as a prescription devices that reduce intraocular pressure by producing a series of lesions in the ciliary body and/or trabecular meshwork induced by high intensity focused ultrasound energy. They are intended for treating glaucoma in patients who (**1**) are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery and (**2**) have failures on maximally tolerated drug therapy. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-05-20/pdf/2024-10895.pdf?ref=fdaweb.com).