Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device

Consumer information, labelling (TBT); Protection of human health or safety (TBT)

Ultrasound cyclodestructive device

Link to ePing

03.120 - Quality; 03.120 - Quality; 11.040 - Medical equipment; 11.040 - Medical equipment

Human health; Human health

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.This order is effective 20 June 2024.Title 21 Code of Federal Regulations (CFR) Part 886This final amendment; final order and the proposed order notified as G/TBT/N/USA/1412 are identified by Docket Number FDA-2018-N-3074. The docket, which provides access to primary and supporting documents as well as comments received, should be accessible from Regulations.gov at https://www.regulations.gov/docket/FDA-2018-N-3074/document. Documents are also accessible from Regulations.gov by searching the Docket Number. 

1:File here 2:File here 3:File here 4:File here 5:File here

EN:File here

FR:File here

ES:File here

Active Inactive