Corneal Inlay Inserter Handle
The Corneal Inlay Inserter Handle is a hand-held ophthalmic accessory device intended for use with a corneal inlay inserter, extending the length of the inserter to aid in delivering the corneal inlay implant during ophthalmic surgery. It is classified as FDA Class 1, with no premarket notification required, under regulation 886.4355 in the Ophthalmic specialty. The product code is QGJ. It is not itself an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGJ
- Device Class
- FDA class 1
- Regulation Number
- 886.4355
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.