21 CFR 886.3130 — Conformer, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3130
Identification
An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQN | Conformer, Ophthalmic | 2 | 7 | |
| NQB | Conformer, Ophthalmic, Biological Tissue | 2 | 1 | Implant |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | 2 | 2 | Implant |
| QWU | Prosthesis, Eyelid Spacer/Graft, Polymer | 2 | 1 | Implant |
Special Controls
HQN — Conformer, Ophthalmic
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
eCFR
NQB — Conformer, Ophthalmic, Biological Tissue
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
eCFR
NXM — Prosthesis, Eyelid Spacer/Graft, Biologic
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
eCFR
QWU — Prosthesis, Eyelid Spacer/Graft, Polymer
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
eCFR
