HLL · Class II · 21 CFR 886.1510

FDA Product Code HLL: Monitor, Eye Movement

Leading manufacturers include C. Light Technologies, Inc..

4
Total
4
Cleared
328d
Avg days
1988
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Monitor, Eye Movement Devices (Product Code HLL)

4 devices
1–4 of 4

About Product Code HLL - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code HLL since 1988, with 4 receiving FDA clearance (average review time: 328 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

HLL devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →