Product Code: HPB FDA class 1 21 CFR 886.1410

Clip, Lens, Trial, Ophthalmic

Ophthalmic

An Ophthalmic Trial Lens Clip is a small device used to attach trial lenses to a patient's existing spectacle frame or to a trial frame, allowing temporary addition of corrective lenses during an eye examination to assess the effect of various lens powers on visual acuity. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HPB and is regulated under 21 CFR 886.1410, within the Ophthalmic medical specialty.

510(k)s
0
FEI Numbers
27
Registration Numbers
27
Unique Applicants
0
Years Active

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Basic Information

Product Code
HPB
Device Class
FDA class 1
Regulation Number
886.1410
Medical Specialty
Ophthalmic
Review Panel
OP
Submission Type
4

Device Characteristics

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

FEI Numbers

This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.