Device |
tomography, optical coherence |
Regulation Description |
Ophthalmoscope. |
Definition |
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases. |
Physical State |
Computerized imaging device consisting of light sources and beam delivery and scanning optics. |
Technical Method |
Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry. |
Target Area |
Eye. |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | OBO |
Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
510(k)
|
Regulation Number |
886.1570
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |