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PJZClass II

Camera, Ophthalmic, General-Use

21 CFR 886.1120 / Ophthalmic
FDA source (opens on fda.gov)

PJZ is the FDA product code for Camera, Ophthalmic, General-Use, a class II device type, regulated under 21 CFR 886.1120. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PJZ
Device name
Camera, Ophthalmic, General-Use
FDA definition
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.
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order