DeviceClearance

Product code NCB— Ophthalmic

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

Classification name
Weights, Eyelid, Implantable
Device class
Class 2
Regulation
21 CFR 886.5700
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)”

— U.S. Food and Drug Administration, device classification record for product code NCB under 21 CFR 886.5700, via openFDA

Market context for product code NCB

FDA has cleared 1 device under product code NCB, all in 2021, 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.

Top applicants under product code NCB

Recent clearances under product code NCB

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