Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is also establishing special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on valid scientific evidence. For this class II device, instead of a premarket approval application, manufacturers may submit a premarket notification, i.e., a 510(k) submission, and obtain FDA clearance of the device before marketing it.
Abstract as published in the Federal Register.
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