Instrument, Measuring, Stereopsis
The Stereopsis Measuring Instrument is an ophthalmic diagnostic device used to quantify a patient's ability to perceive depth through binocular disparity, providing objective assessment of stereoacuity in conditions such as amblyopia, strabismus, and binocular vision disorders. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without any premarket notification submission. The product code is HLC, regulated under 21 CFR 886.1460, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
Research product code HLC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HLC
- Device Class
- FDA class 1
- Regulation Number
- 886.1460
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.