Device |
lens, contact, orthokeratology, overnight |
Regulation Description |
Rigid gas permeable contact lens. |
Definition |
Temporary reduction of myopia or refractive error. |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | NUU |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
PMA
|
Regulation Number |
886.5916
|
Device Class |
3
|
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
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |