| Device |
ophthalmic syringe |
| Regulation Description |
Piston syringe. |
| Definition |
An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye. |
| Physical State |
The Ophthalmic Syringe consists of a syringe barrel, a plunger, and may include a needle. The plunger and barrel are typically made of a polymeric material whereas the needle is made from stainless steel. |
| Technical Method |
Ophthalmic syringes are operated manually by pushing or pulling the plunger to expel or withdraw a liquid. The device is not to be used with a delivery system. |
| Target Area |
The device is intended for injections into the eye. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QLY |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5860
|
|---|
| 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 |
