| Device |
camera, ophthalmic, non-prescription |
| Regulation Description |
Ophthalmic camera. |
| Definition |
Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional. |
| Physical State |
A non-prescription ophthalmic camera is an AC- or battery- powered device designed for true color or monochrome imaging, consisting of image forming lens, aperture, and a sensitive photodetector array in the image plane. It is designed to be operated by a lay person for self-imaging. |
| Technical Method |
A non-prescription ophthalmic camera is designed to be operated outside the professional clinic environment. It is designed for self-imaging by the lay person, storage and delivery of the collected images to the healthcare professional for evaluation. The camera should meet the same performance standards as an ophthalmic camera indicated for prescription use, including currently recognized versions of ISO 10940 and ANSI Z80.36. |
| Target Area |
Human eye and the surrounding area. |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | QZP |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.1120
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
