FDA Product Code HJO: Biomicroscope, Slit-lamp, Ac-powered

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 510(k) Review Time - HJO Product Code

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 →

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