PJZ · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1120
Classification
FDA Product Code
PJZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 886.1120
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.