Caliper, Ophthalmic
An Ophthalmic Caliper is a precision measurement instrument used in eye care and surgery to measure distances on the eye or surrounding structures, such as the corneal diameter, incision width, or tissue dimensions during surgical planning and execution. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket submission. It carries product code HOE and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HOE
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881094 | KOI(TM) BLADE GAUGE, MODEL KOI-132 | Apr 01, 1988 | Substantially Equivalent | CooperVision, Inc. |
| K813315 | CALIPER-OPTHALMIC | Mar 01, 1982 | Substantially Equivalent | Design Research Assoc., Inc. |
| K820050 | KREMER BLADE GAUGE | Feb 24, 1982 | Substantially Equivalent | Accutome, Inc. |
| K812011 | BLADE GAUGE | Jul 28, 1981 | Substantially Equivalent | Koi, Inc. |
| K801937 | BLEPHAROMETER | Sep 16, 1980 | Substantially Equivalent | Aztec Medical Products, Inc. |
| K792383 | KELMAN DIPSTICK | Dec 11, 1979 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K781715 | RULER, WECK SCOTT | Dec 04, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 162 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 162 registration numbers. Click on an entry to view related FDA registrations.