MMC · Dilator, Expansive Iris (Accessory)
Ophthalmic · 21 CFR 886.4150 · Class 2
Overview
| Product Code | MMC |
|---|---|
| Device Name | Dilator, Expansive Iris (Accessory) |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
Classification Rationale
Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, 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, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (0)
No cleared devices on record.
