OJK · Eye Tray
Ophthalmic · 21 CFR 886.4790 · Class 2
Overview
| Product Code | OJK |
|---|---|
| Device Name | Eye Tray |
| Regulation | 21 CFR 886.4790 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic 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 the limitations in § 886.9.
Special Controls
*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 the limitations in § 886.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
