Product Code: HOC FDA class 1 21 CFR 886.4350

Clip, Iris Retractor

Ophthalmic

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.

510(k)s
2
FEI Numbers
67
Registration Numbers
68
Unique Applicants
2
Years Active
4

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K871474 PART #860070 ULTRAPAK & #860075 ULTRAPAK
K830871 PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION

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.