DeviceClearance

Product code NXM— Ophthalmic

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT

Classification name
Prosthesis, Eyelid Spacer/Graft, Biologic
Device class
Class 2
Regulation
21 CFR 886.3130
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

FDA classification definition

“For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.”

— U.S. Food and Drug Administration, device classification record for product code NXM under 21 CFR 886.3130, via openFDA

Market context for product code NXM

FDA has cleared 2 devices under product code NXM between 2006 and 2009, filed by 1 applicant company. 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 NXM

Recent clearances under product code NXM

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