# Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
> **Food and Drug Administration** · Final amendment; final order. · Published 2024-05-20 · Effective 2024-06-20 · 89 FR 43743
## Document
- **Document number:** 2024-10895
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 43743
- **CFR reference:** 21 CFR 886
- **Publication date:** 2024-05-20
- **Effective date:** 2024-06-20
- **HHS docket:** Docket No. FDA-2018-N-3074
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/05/20/2024-10895/ophthalmic-devices-reclassification-of-ultrasound-cyclodestructive-device)
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