Device |
folders and injectors, intraocular lens (iol) |
Regulation Description |
Intraocular lens guide. |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | MSS |
Premarket Review |
Office of Device Evaluation
(ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices
(DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
|
Submission Type |
510(k)
|
Regulation Number |
886.4300
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Recognized Consensus Standard
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|