| Device |
blade, keratome, reprocessed |
| Regulation Description |
Keratome. |
| Definition |
Blade for keratome to make flap in cornea for lasik refractive surgery.Same as previously cleared blade for keratomes, product codes hmy and hno, except this is reprocessed. |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | NKY |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.4370
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Guidance for Industry and FDA Staff - Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
