Device |
apparatus, cutting, radiofrequency, electrosurgical, ac-powered |
Regulation Description |
Radiofrequency electrosurgical cautery apparatus. |
Definition |
Used to perform anterior capsulotomy during cataract surgery |
Physical State |
RF power console and handpiece. The handpiece has the cutting element that delivers energy for capsulotomy. |
Technical Method |
A corneal incision is made into the anterior chamber of the eye. A cutting element is inserted through the incision and centered on the lens capsule. Energy is directed to the cutting element, creating the capsulotomy. The cutting element is removed from the anterior chamber. |
Target Area |
Cornea of the eye |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | PUL |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
510(k)
|
Regulation Number |
886.4100
|
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
|
Third Party Review |
Not Third Party Eligible |