21 CFR 886.4150 — Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4150
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 2 | 16 | 3rd Party |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 149 | 3rd Party |
| MLZ | Vitrectomy, Instrument Cutter | 2 | 4 | 3rd Party |
| MMC | Dilator, Expansive Iris (Accessory) | 2 | 0 | 3rd Party |
| MSR | Tubing, Replacement, Phacofragmentation Unit | 2 | 5 | |
| QDY | Vitrectomy Kit | 2 | 0 |
Special Controls
HKP — Instrument, Vitreous Aspiration And Cutting, Battery-Powered
*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.
eCFR
HQE — Instrument, Vitreous Aspiration And Cutting, Ac-Powered
*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.
eCFR
MLZ — Vitrectomy, Instrument Cutter
*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.
eCFR
MMC — Dilator, Expansive Iris (Accessory)
*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.
eCFR
MSR — Tubing, Replacement, Phacofragmentation Unit
*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.
eCFR
QDY — Vitrectomy Kit
*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.
eCFR
