LZR — Ultrasound, Cyclodestructive Class II
FDA product code LZR covers "Ultrasound, Cyclodestructive", a Class II medical device regulated under 21 CFR 886.5350. Submissions are reviewed by the Ophthalmic panel.
Classification Details
- Product Code
- LZR
- Device Class
- Class II
- Regulation Number
- 886.5350
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
An ultrasound cyclodestructive device uses high intensity focused ultrasound (HIFU) energy to create lesions in the ciliary body and/or trabecular meshwork to reduce intraocular pressure in glaucoma patients.