Clip, Iris Retractor
An Iris Retractor Clip is a small ophthalmic device used to mechanically dilate the pupil by retracting the iris margin, providing improved intraoperative visualization during cataract surgery in patients with inadequate pupil dilation. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification. It carries product code HOC and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HOC
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 68 registration numbers. Click on an entry to view related FDA registrations.