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 |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
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 |