View all text of Subpart E [§ 886.4070 - § 886.4855]
§ 886.4360 - Ocular surgery irrigation device.
(a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.
(b) Classification. Class I (general 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.