Hoskins-Barkan Goniotomy Lens 10MM
FDA 510(k) K875330 · Ocular Instruments, Inc.
510(k) numberK875330
Submission
- Device name
- Hoskins-Barkan Goniotomy Lens 10MM
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- December 30, 1987
- Decision date
- February 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1385
- Specialty
- Ophthalmic
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|---|---|---|---|
| K201909 | RxSight Contact LensHJK · Traditional | Rxsight, Inc. | 09/10/2020SE |
| K173944 | Endocular Viewing Lenses and Silicone RingHJK · Traditional | Phakos | 10/25/2018SE |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special | Volk Optical, Inc. | 08/18/2015SE |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and ProductsHJK · Traditional | Sensor Medical Technology, LLC | 12/16/2014SE |
| K051630 | Super View Disposable Biom Lens SetHJK · Traditional | Insight Instruments, Inc. | 06/29/2005SE |
| K051103 | Haag-Streit Contact Glasses Stery Cup, AccessoryHJK · Traditional | Haag-Streit USA, Inc. | 06/07/2005SE |
| K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…HJK · Special | Volk Optical, Inc. | 03/28/2005SE |
| K033950 | Dorc Vitrectomy Lenses, Model 1284 SeriesHJK · Traditional | Dutch Ophthalmic Research Center (D.O.R.C.) | 02/20/2004SE |
| K030054 | Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional | Fci Ophthalmics, Inc. | 02/26/2003SE |
| K023221 | Contact Laser & Diagnostic LensesHJK · Special | Volk Optical, Inc. | 10/11/2002SE |
More from Volk Optical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K014170 | Staurenghi Wide Field Scanning Laser LensHJK · Traditional | 03/04/2002SE |
| K012096 | Disposable Vitrectomy LensHJK · Traditional | 08/24/2001SE |
| K933976 | Mandelkorn Suture Lysis LensHJK · Traditional | 11/08/1994SE |
| K933264 | Ritch Nylon Suture Laser LensHJK · Traditional | 10/31/1994SE |
| K941420 | 50 Degree Hri Prism LensHJK · Traditional | 08/29/1994SE |
| K935302 | Osher Surgical Gonio/Posterior Pole LensHKS · Traditional | 04/01/1994SE |
| K923670 | Byrne Expulsive LensHJI · Traditional | 11/16/1992SE |
| K921414 | Trokel /3 Gonio Laser LensLQJ · Traditional | 11/16/1992SE |
| K914051 | Pediatric Vitrectomy Lens SetHJK · Traditional | 12/09/1991SE |
| K914117 | Landers High Refractive Index Vitrectomy Lens SetHJK · Traditional | 11/13/1991SE |
Questions and answers
When was Hoskins-Barkan Goniotomy Lens 10MM cleared by the FDA?
Hoskins-Barkan Goniotomy Lens 10MM (K875330) received a 510(k) decision of Substantially Equivalent on February 26, 1988, 58 days after the submission was received.
What is the product code of K875330?
The FDA product code is HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1385.