DeviceClearance

Product code MSS— Ophthalmic

RxSight Insertion Device

Classification name
Folders And Injectors, Intraocular Lens (Iol)
Device class
Class 1
Regulation
21 CFR 886.4300
Advisory panel
Ophthalmic
Total cleared
63
First cleared
Most recent

Market context for product code MSS

FDA has cleared 63 devices under product code MSS between 1997 and 2026, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code MSS

Adverse events under product code MSS

product code MSS
Injury
385
Malfunction
2,033
Total
2,418

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MSS

Data sourced from openFDA. This site is unofficial and independent of the FDA.