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U.S. Department of Health and Human Services

Product Classification

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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 CodePLX
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
    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