HKS
10 FDA 510(k) clearances · Product code
49 daysmedian time to decision
150 days90th percentile
10clearances measured
FDA profile
- Official device name
- Prism, Gonioscopic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1660
- Medical specialty
- Ophthalmic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FAMILY OF DISPOSABLE LENSES (K140368) | Sensor Medical Technology, LLC | 2014-04-29 |
| OSHER SURGICAL GONIO/POSTERIOR POLE LENS (K935302) | Ocular Instruments, Inc. | 1994-04-01 |
| TWO MIRROR GONIO LENS (K895846) | Ocular Instruments, Inc. | 1989-12-18 |
| MCINTYRE SURGICAL GONIOLENS (K890977) | Ocular Instruments, Inc. | 1989-05-23 |
| ABRAHAM IRIDECTOMY LENS (YAG LASER) (K862713) | Ocular Instruments, Inc. | 1986-08-21 |
| KARICKHOFF DIAGNOSTIC/LASER LENS (K862692) | Ocular Instruments, Inc. | 1986-08-21 |
| RITCH TRABECULOPLASTY LASER LENS (K862512) | Ocular Instruments, Inc. | 1986-07-11 |
| SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM (K862024) | Ocular Instruments, Inc. | 1986-07-11 |
| KETA HAND-HELD TONOMETER (K861027) | Keta Corp. | 1986-05-06 |
| DORC ADJUSTABLE IMAGE CONTACTS (K830169) | Jedmed Instrument Co. | 1983-02-07 |
Track HKS automatically
Every clearance here is in the API, with alerts when new ones post.