21 CFR 886.4170 — Unit, Cryophthalmic
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4170
Identification
A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HPS | Unit, Cryophthalmic | 2 | 11 | 3rd Party |
| HQA | Unit, Cryotherapy, Ophthalmic | 2 | 4 | 3rd Party |
| HRN | Unit, Cryophthalmic, Ac-Powered | 2 | 10 | 3rd Party |
