LPN · Class II · 21 CFR 886.5928

FDA Product Code LPN: Accessories, Soft Lens Products

Leading manufacturers include Bausch & Lomb, Incorporated.

120
Total
120
Cleared
129d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Accessories, Soft Lens Products Devices (Product Code LPN)

120 devices
1–24 of 120

About Product Code LPN - Regulatory Context

510(k) Submission Activity

120 total 510(k) submissions under product code LPN since 1985, with 120 receiving FDA clearance (average review time: 129 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

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