Product code HKS
- Device name
- Prism, Gonioscopic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1660
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140368 | FAMILY OF DISPOSABLE LENSES | Sensor Medical Technology, LLC | 2014-04-29 |
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | Ocular Instruments, Inc. | 1994-04-01 |
| K895846 | TWO MIRROR GONIO LENS | Ocular Instruments, Inc. | 1989-12-18 |
| K890977 | MCINTYRE SURGICAL GONIOLENS | Ocular Instruments, Inc. | 1989-05-23 |
| K862692 | KARICKHOFF DIAGNOSTIC/LASER LENS | Ocular Instruments, Inc. | 1986-08-21 |
| K862713 | ABRAHAM IRIDECTOMY LENS (YAG LASER) | Ocular Instruments, Inc. | 1986-08-21 |
| K862024 | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | Ocular Instruments, Inc. | 1986-07-11 |
| K862512 | RITCH TRABECULOPLASTY LASER LENS | Ocular Instruments, Inc. | 1986-07-11 |
| K861027 | KETA HAND-HELD TONOMETER | Keta Corp. | 1986-05-06 |
| K830169 | DORC ADJUSTABLE IMAGE CONTACTS | Jedmed Instrument Co. | 1983-02-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811608019994 | Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX) | VOLK OPTICAL INC. | 2026-04-07 |
| 00811608019949 | Single Use GonioPro Surgical Lens + Handle (VSGLHD) | VOLK OPTICAL INC. | 2026-02-04 |
| 10811608019922 | Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD) | VOLK OPTICAL INC. | 2026-02-04 |
| 10811608019915 | Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD) | VOLK OPTICAL INC. | 2026-02-04 |
| 10811608019908 | Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD) | VOLK OPTICAL INC. | 2026-02-04 |
| 00811608019895 | GonioPro Surgical Lens + Handle (VSGLHACS) | VOLK OPTICAL INC. | 2026-02-04 |
| 10811608019939 | Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD) | VOLK OPTICAL INC. | 2026-02-04 |
| 10811608019946 | Single Use GonioPro Surgical Lens + Handle (VSGLHD) | VOLK OPTICAL INC. | 2026-02-04 |
| 00811608019932 | Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD) | VOLK OPTICAL INC. | 2026-02-04 |
| 00811608019925 | Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD) | VOLK OPTICAL INC. | 2026-02-04 |
| 00811608019918 | Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD) | VOLK OPTICAL INC. | 2026-02-04 |
| 00811608019901 | Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD) | VOLK OPTICAL INC. | 2026-02-04 |
| 10841668146580 | Glaukos | KATENA PRODUCTS, INC. | 2026-01-15 |
| 00811608019802 | Rapid SLT | VOLK OPTICAL INC. | 2025-08-07 |
| 00194613121976 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613121846 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613121853 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613121952 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613122621 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613122645 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613122652 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613123246 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 04049584034229 | GONIO ready® CL | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2025-05-09 |
| 04049584034212 | GONIO ready® CL | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2025-05-09 |
| 04049584034472 | GONIO ready® 175 for f=175 | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2023-03-27 |
| 04049584034465 | GONIO ready® 200 for f=200 | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2023-03-27 |
| 00811608019130 | Single Use SLT | VOLK OPTICAL INC. | 2020-09-25 |
| 00811608019123 | Single Use 3-Mirror Gonio | VOLK OPTICAL INC. | 2020-09-25 |
| 00811608019116 | Single Use 4-Mirror Gonio | VOLK OPTICAL INC. | 2020-09-25 |
| 00630238008228 | Three Mirror Universal Gonio Diagnostic Lens 18mm O.D. | OCULAR INSTRUMENTS, INC. | 2018-08-14 |