HKS · Prism, Gonioscopic
Ophthalmic · 21 CFR 886.1660 · Class 1
Overview
| Product Code | HKS |
|---|---|
| Device Name | Prism, Gonioscopic |
| Regulation | 21 CFR 886.1660 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140368 | FAMILY OF DISPOSABLE LENSES | Sensor Medical Technology, LLC | Apr 29, 2014 | SESE |
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | Ocular Instruments, Inc. | Apr 1, 1994 | SESE |
| K895846 | TWO MIRROR GONIO LENS | Ocular Instruments, Inc. | Dec 18, 1989 | SESE |
| K890977 | MCINTYRE SURGICAL GONIOLENS | Ocular Instruments, Inc. | May 23, 1989 | SESE |
| K862713 | ABRAHAM IRIDECTOMY LENS (YAG LASER) | Ocular Instruments, Inc. | Aug 21, 1986 | SESE |
| K862692 | KARICKHOFF DIAGNOSTIC/LASER LENS | Ocular Instruments, Inc. | Aug 21, 1986 | SESE |
| K862512 | RITCH TRABECULOPLASTY LASER LENS | Ocular Instruments, Inc. | Jul 11, 1986 | SESE |
| K862024 | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | Ocular Instruments, Inc. | Jul 11, 1986 | SESE |
| K861027 | KETA HAND-HELD TONOMETER | Keta Corp. | May 6, 1986 | SESE |
| K830169 | DORC ADJUSTABLE IMAGE CONTACTS | Jedmed Instrument Co. | Feb 7, 1983 | SESE |
Top Applicants
- Ocular Instruments, Inc. — 7 clearances
- Jedmed Instrument Co. — 1 clearance
- Keta Corp. — 1 clearance
- Sensor Medical Technology, LLC — 1 clearance
