FDA Product Code LZU: Plug, Punctum
Leading manufacturers include Oasis Medical, Inc. and Bio Optics Co., Ltd..
FDA 510(k) Cleared Plug, Punctum Devices (Product Code LZU)
About Product Code LZU - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code LZU since 1989, with 49 receiving FDA clearance (average review time: 111 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 LZU have taken an average of 57 days to reach a decision - down from 112 days historically, suggesting improved FDA processing for this classification.
LZU devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →