Iol Tray
The IOL Tray is a Class 1 ophthalmic convenience kit device used as a tray for intraocular lenses, established as a convenience kit under the FDA's May 1997 interim regulatory guidance and subject to enforcement discretion without requiring a 510(k) if all criteria in the guidance are met. It falls under regulation 886.4350 in the Ophthalmic specialty. The product code is QDV. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDV
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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.