Pupillometer, Manual
The Manual Pupillometer is a non-powered ophthalmic instrument used to measure pupil diameter, used in fitting contact lenses, monitoring drug effects, or evaluating neurological reflexes, by comparing the pupil against a series of calibrated reference circles. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without any premarket notification. The product code is HLH, regulated under 21 CFR 886.1700, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
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Basic Information
- Product Code
- HLH
- Device Class
- FDA class 1
- Regulation Number
- 886.1700
- 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 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.