Target, Fusion And Stereoscopic
The Fusion and Stereoscopic Target is an ophthalmic accessory used in binocular vision testing and vision therapy, providing separate visual stimuli to each eye to assess and train stereoacuity, fusion amplitude, and binocular coordination. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HLP, regulated under 21 CFR 886.1880, 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
- HLP
- Device Class
- FDA class 1
- Regulation Number
- 886.1880
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883471 | VKG 1000, VIDEO KERATOMETER | Nov 08, 1988 | Substantially Equivalent | Technitex, Inc. |
| K874251 | WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT | Jan 11, 1988 | Substantially Equivalent | Richmond Products, Inc. |
| K874250 | THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. | Jan 11, 1988 | Substantially Equivalent | Richmond Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.