| Device |
manual refractor, 3d display |
| Regulation Description |
Manual refractor. |
| Definition |
A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye. |
| Physical State |
The 3D Display Manual Refractor is a portable electronic software-controlled device. |
| Technical Method |
The 3D Display Manual Refractor is a prescription device. The device provides the eye healthcare professional capabilities of digitally presenting different optotypes to the patient on three dimensional display at various depths and to determine the refractive errors through the patients' subjective descriptions of how well they can see the presented optotypes. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | SBI |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
886.1770
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
