FDA Product Code MSS: Folders And Injectors, Intraocular Lens (iol)
Leading manufacturers include Alcon Laboratories, Inc., Bausch & Lomb, Incorporated and Medicel AG.
FDA 510(k) Cleared Folders And Injectors, Intraocular Lens (iol) Devices (Product Code MSS)
About Product Code MSS - Regulatory Context
510(k) Submission Activity
62 total 510(k) submissions under product code MSS since 1997, with 62 receiving FDA clearance (average review time: 130 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under MSS have taken an average of 47 days to reach a decision - down from 133 days historically, suggesting improved FDA processing for this classification.
MSS devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →