DeviceClearance

Product code NQB— Ophthalmic

AMNIOLENS

Classification name
Conformer, Ophthalmic, Biological Tissue
Device class
Class 2
Regulation
21 CFR 886.3130
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.”

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

Market context for product code NQB

FDA has cleared 1 device under product code NQB, all in 2003, 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 NQB

Recent clearances under product code NQB

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