| Device |
ophthalmic femtosecond laser |
| Regulation Description |
Ophthalmic laser. |
| Definition |
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery. |
| Physical State |
The device consists of a laser console, a computer with grahic user interface, a beam delivery system that positions and focuses the laser beam, and a patient interface system that flattens the cornea and holds the patient's eye still during the surgical procedure. |
| Technical Method |
A Nd:glass solid state laser generates sub-picosecond pulses at a 15 kHz repetition rate. The beam is focused at high convergence to a spot diameter <6 microns at the target location. Tissue is vaporized in a very small region at the focal point. A computer-controlled 3-dimensional scanning system positions the beam with micron-scale accuracy. |
| Target Area |
Anterior lens capsule of the eye. |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | OOE |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.4390
|
|---|
| 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 |
