Data / Federal rules / 2024-10895
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
The Food and Drug Administration published this final rule in the Federal Register on May 20, 2024. It took effect on June 20, 2024.
SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.
What the agency says
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.
Key facts
- Document number
- 2024-10895
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- May 20, 2024
- Takes effect
- June 20, 2024
- Dates
- This order is effective June 20, 2024.
- Docket
- Docket No. FDA-2018-N-3074
- Code of Federal Regulations
- 21 CFR 886
- Topics
- Medical devices; Ophthalmic goods and services
- Pages
- 5
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on ophthalmic goods and services · Published in May 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.