FDA Product Code HJO: Biomicroscope, Slit-lamp, Ac-powered
Leading manufacturers include Carl Zeiss Vision GmbH and Cylite Pty. , Ltd..
FDA 510(k) Cleared Biomicroscope, Slit-lamp, Ac-powered Devices (Product Code HJO)
About Product Code HJO - Regulatory Context
510(k) Submission Activity
108 total 510(k) submissions under product code HJO since 1980, with 108 receiving FDA clearance (average review time: 127 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under HJO have taken an average of 107 days to reach a decision - down from 127 days historically, suggesting improved FDA processing for this classification.
HJO devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →