PJZ
- 产品代码
- PJZ
- 器械名称
- Camera, Ophthalmic, General-Use
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 886.1120
- FDA 专业组
- Ophthalmic
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
FDA 分类定义
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of diagnostic or aid in diagnosis claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.
FDA 官方分类页： PJZ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。