HKSClass I

Prism, Gonioscopic

21 CFR 886.1660 / Ophthalmic

HKS is the FDA product code for Prism, Gonioscopic, a class I device type, regulated under 21 CFR 886.1660. As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2014-04-29, and one recall.

Classification record

Product code: HKS
Device name: Prism, Gonioscopic
Regulation: 21 CFR 886.1660
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 1

Clearances, product code HKS

By decision year

10 clearances under product code HKS with a decision year between 1983 and 2014, 1986 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code HKS by decision year
Year	Clearances
1983	1
1986	5
1989	2
1994	1
2014	1

Applicants with the most clearances

Product code HKS

Applicants holding the most 510(k) clearances under product code HKS
Applicant	Clearances
Ocular Instruments, Inc.	7
JEDMED Instrument Company	1
Keta Corp.	1
Sensor Medical Technology, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order