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Tear Duct Occluder

Page Type
Product Code
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
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.5838
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5838 Nasolacrimal compression device

§ 886.5838 Nasolacrimal compression device.

(a) Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

[81 FR 37500, June 10, 2016]

Tear Duct Occluder

Page Type
Product Code
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
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.5838
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5838 Nasolacrimal compression device

§ 886.5838 Nasolacrimal compression device.

(a) Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

[81 FR 37500, June 10, 2016]