Cup, Eye
The Eye Cup (product code LXQ) is a small cup-shaped device used to bathe, irrigate, or collect fluid from the eye, commonly used for ocular irrigation in cases of eye irritation or to administer eye washes. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Ophthalmic (OP) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LXQ
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- OP
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151575 | Dynarex Eye Cups | Sep 01, 2015 | Substantially Equivalent | Dynarex Corporation |
| K140409 | FLENTS PLASTIC EYE WASH CUP | Jul 09, 2014 | Substantially Equivalent | Apothecary Products, Inc. |
| K051414 | EYE CUP, STERILE 1 AND NON STERILE | Jun 16, 2005 | Substantially Equivalent | Tollot Pty.Ltd.(Aaxis Pacific) |
| K971134 | VISTA EYESHOWER | Nov 04, 1997 | Substantially Equivalent | John Branch |
| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | May 13, 1988 | Substantially Equivalent | Advantage Diagnostics Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.