Prism, Gonioscopic
The Gonioscopic Prism is an ophthalmic diagnostic lens placed on the surface of the cornea with a coupling fluid to allow visualization of the iridocorneal angle, enabling evaluation of the drainage angle in conditions such as glaucoma. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HKS, regulated under 21 CFR 886.1660, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HKS
- Device Class
- FDA class 1
- Regulation Number
- 886.1660
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140368 | FAMILY OF DISPOSABLE LENSES | Apr 29, 2014 | Substantially Equivalent | Sensor Medical Technology, LLC |
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | Apr 01, 1994 | Substantially Equivalent | Ocular Instruments, Inc. |
| K895846 | TWO MIRROR GONIO LENS | Dec 18, 1989 | Substantially Equivalent | Ocular Instruments, Inc. |
| K890977 | MCINTYRE SURGICAL GONIOLENS | May 23, 1989 | Substantially Equivalent | Ocular Instruments, Inc. |
| K862713 | ABRAHAM IRIDECTOMY LENS (YAG LASER) | Aug 21, 1986 | Substantially Equivalent | Ocular Instruments, Inc. |
| K862692 | KARICKHOFF DIAGNOSTIC/LASER LENS | Aug 21, 1986 | Substantially Equivalent | Ocular Instruments, Inc. |
| K862512 | RITCH TRABECULOPLASTY LASER LENS | Jul 11, 1986 | Substantially Equivalent | Ocular Instruments, Inc. |
| K862024 | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | Jul 11, 1986 | Substantially Equivalent | Ocular Instruments, Inc. |
| K861027 | KETA HAND-HELD TONOMETER | May 06, 1986 | Substantially Equivalent | Keta Corp. |
| K830169 | DORC ADJUSTABLE IMAGE CONTACTS | Feb 07, 1983 | Substantially Equivalent | Jedmed Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.