OCUTOME MODEL 8000
Device Facts
| Record ID | K791898 |
|---|---|
| Device Name | OCUTOME MODEL 8000 |
| Applicant | Cooper Medical Devices Corp. |
| Product Code | HKP · Ophthalmic |
| Decision Date | Oct 30, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
