DeviceClearance

Product code LXP— Ophthalmic

SCLERAL PLUGS, 19 AND 20 GAUGE

Classification name
Plug, Scleral
Device class
Class 2
Regulation
21 CFR 886.4155
Advisory panel
Ophthalmic
Total cleared
10
First cleared
Most recent

FDA classification definition

“Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.”

— U.S. Food and Drug Administration, device classification record for product code LXP under 21 CFR 886.4155, via openFDA

Market context for product code LXP

FDA has cleared 10 devices under product code LXP between 1983 and 2003, filed by 8 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 LXP

Recent clearances under product code LXP

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