DeviceClearance

Product code LYL— Ophthalmic

3N Contact Lenses Adjunct Cleaner

Classification name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device class
Class 2
Regulation
21 CFR 886.5928
Advisory panel
Ophthalmic
Total cleared
22
First cleared
Most recent

Market context for product code LYL

FDA has cleared 22 devices under product code LYL between 1988 and 2022, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LYL

Adverse events under product code LYL

product code LYL
Other
1
Total
1

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 LYL

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