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# Ultrasound Cyclodestructive Device Reclassification Proposed
- URL: https://www.fdaweb.com/ultrasound-cyclodestructive-device-reclassification-proposed/
- Published: 2018-09-25T12:00:00.000Z
- Updated: 2026-09-15T00:33:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142436

*Federal Register* notice: FDA has issued a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class 3 device (regulated under product code LZR) into Class 2 (special controls), subject to a premarket notification 510(k) submission. This device is indicated for treating refractory glaucoma; it is intended for patients who are refractory to or are poor candidates for laser or surgical treatment and fail to achieve target intraocular pressures on maximally tolerated drug therapy. The device is designed to reduce intraocular pressure by producing a series of lesions in the ciliary body and trabecular meshwork induced by high intensity focused ultrasound energy. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20763.pdf?ref=fdaweb.com).