Product Code: HMH FDA class 1 21 CFR 886.1750

Rack, Skiascopic

Ophthalmic

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.

510(k)s
2
FEI Numbers
12
Registration Numbers
12
Unique Applicants
2
Years Active
0

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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

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

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K844364 SKIASCOPIC RACKS
K843195 VISITEC FLIERINGA-LEGRAND FIXATION RING

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.