NQB

Conformer, Ophthalmic, Biological Tissue

Product code

NQB

Device name

Conformer, Ophthalmic, Biological Tissue

Device class

Class 2

21 CFR

21 CFR 886.3130

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

Flag

Implant

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).