Rack, Skiascopic
The Skiascopic Rack is an ophthalmic accessory consisting of a series of trial lenses mounted on a rack or bar arrangement, used during retinoscopy (skiascopy) to quickly introduce lenses for objective refractive assessment. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification requirement. The product code is HMH, regulated under 21 CFR 886.1750, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HMH
- Device Class
- FDA class 1
- Regulation Number
- 886.1750
- 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 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.