21 CFR 886.4610 — Applicator, Ocular Pressure
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4610
Identification
An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LCC | Applicator, Ocular Pressure | 2 | 6 | 3rd Party |