FDA Product Code ORZ: Eyelid Thermal Pulsation System
Therapeutic Application Of Heat And Massage To The Eyelids.
Leading manufacturers include Sight Sciences, Inc. and Novoxel , Ltd..
FDA 510(k) Cleared Eyelid Thermal Pulsation System Devices (Product Code ORZ)
About Product Code ORZ - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code ORZ since 2011, with 11 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ORZ have taken an average of 245 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.
ORZ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →