Device |
knife, intraocular pressure lowering |
Regulation Description |
Electrosurgical cutting and coagulation device and accessories. |
Definition |
A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma |
Physical State |
manual, non-powered, knife |
Technical Method |
Uses a manual, non-powered, knife to cut trabecular meshwork |
Target Area |
trabecular meshwork |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Ophthalmic |
Product Code | QUQ |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4400
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |