NQB · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3130
Classification
FDA Product Code
NQB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 886.3130
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.