FDA Product Code LPL: Lenses, Soft Contact, Daily Wear
Under FDA product code LPL, soft contact lenses for daily wear are cleared for the correction of refractive errors including myopia, hyperopia, and astigmatism.
These hydrophilic lenses conform to the shape of the cornea and correct vision by refracting light onto the retina. Daily wear lenses are removed nightly for cleaning and disinfection, distinguishing them from extended wear lenses cleared under other product codes.
LPL devices are Class II medical devices, regulated under 21 CFR 886.5925 and reviewed by the FDA Ophthalmic panel.
Leading manufacturers include Alcon Laboratories, Inc., Pegavision Corporation and St. shine Optical Co., Ltd..
FDA 510(k) Cleared Lenses, Soft Contact, Daily Wear Devices (Product Code LPL)
About Product Code LPL - Regulatory Context
510(k) Submission Activity
483 total 510(k) submissions under product code LPL since 1994, with 483 receiving FDA clearance (average review time: 116 days).
Submission volume has remained relatively stable over the observed period, with 23 submissions in the last 24 months.
FDA Review Time
Recent submissions under LPL have taken an average of 167 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
LPL devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →