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Conformer, Ophthalmic, Biological Tissue

FDA product code NQB · 1 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.3130
Review panel
OP
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2003-12-12 – 2003-12-12

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.

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