DeviceClearance

Product code LXS— Ophthalmic

ISL QC 2000

Classification name
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device class
Class 2
Regulation
21 CFR 886.4392
Advisory panel
Ophthalmic
Total cleared
6
First cleared
Most recent

Market context for product code LXS

FDA has cleared 6 devices under product code LXS between 1989 and 2002, filed by 5 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

Top applicants under product code LXS

Recent clearances under product code LXS

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