21 CFR 886.3320 — Implant, Eye Sphere
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3320
Identification
An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Classification Rationale
Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HPZ | Implant, Eye Sphere | 2 | 39 | Implant |
| MQU | Ocular Peg | 2 | 4 | Implant |
| MTZ | Wrap, Implant, Orbital | 2 | 2 | Implant |
| NFM | Expander, Tissue, Orbital | 2 | 2 | Implant |
| PUF | Ocular Peg, Exempt | 2 | 0 | Implant |
Special Controls
HPZ — Implant, Eye Sphere
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
MQU — Ocular Peg
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
MTZ — Wrap, Implant, Orbital
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
NFM — Expander, Tissue, Orbital
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
PUF — Ocular Peg, Exempt
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
