| Device |
tear duct occluder |
| Regulation Description |
Nasolacrimal compression device. |
| Definition |
A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the duct. |
| Physical State |
the frame material (e.g., metal) is durable and flexible enough to appropriately fit the frame to the patient and maintain nose pad placement. The nose pads from which the pressure is applied should include padding to mitigate risk of abrasion. The device also includes a mechanism to maintain consistent pressure during use (e.g., adjustable Velcro strap). |
| Technical Method |
A device of this type uses a nose piece to apply direct pressure to the top of the nasal aspect of the orbital rim to occlude the ducts during application of the pressure. The pressure can be controlled by means of tightening a strap that is worn around a patient's head. The device includes a failure mechanism to protect against excessive pressure. |
| Target Area |
Nasal aspect of orbital rim |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | PLX |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
886.5838
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
