Schepens-Yoshida Video Binocular Indirect Ophthalmscope
FDA 510(k) K951728 · Mira, Inc.
510(k) numberK951728
Submission
- Device name
- Schepens-Yoshida Video Binocular Indirect Ophthalmscope
- Applicant
- Mira, Inc.
Waltham, MA, US - Received
- April 13, 1995
- Decision date
- March 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Other 510(k)s with product code HLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue SoftwareHLI · Traditional | Optovue, Inc. | 02/11/2016SE |
| K150722 | EnFocus 2300, EnFocus 4400HLI · Traditional | Bioptigen, Inc. | 12/02/2015SE |
| K142953 | OCT-CameraHLI · Traditional | Optomedical Technologies GmbH | 03/04/2015SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | Propper Manufacturing Co., Inc. | 09/17/2014SE |
| K133758 | Centervue Macular Integrity AssessmentHLI · Traditional | Centervue S.P.A. | 04/23/2014SE |
| K131939 | Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional | Amico Diagnostic Incorporated | 03/26/2014SE |
| K133892 | Ivue 500HLI · Traditional | Optovue, Inc. | 03/19/2014SE |
| K123316 | Heine Omega 500HLI · Abbreviated | Heine Optotechnik GmbH & Co. KG | 02/26/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | Optovue, Inc. | 01/18/2013SE |
| K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)HLI · Traditional | Bioptigen, Inc. | 05/11/2012SE |
More from Bioptigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950806 | Solid Dilicone Implants, Sdilicone Sponge ImplantsHQX · Traditional | 06/05/1996SE |
| K941495 | Return Path Diathermy HandleHQR · Traditional | 07/15/1994SE |
| K933527 | Modification of Anterior Segment ElectrodesHWA · Traditional | 01/25/1994SE |
| K923629 | Ophthalmic Trichiasis ProbeHPS · Traditional | 10/19/1992SE |
| K894248 | Converter SystemHQE · Traditional | 02/27/1990SE |
| K891601 | Power Operated and Controlled Vitreous ScissorsHQE · Traditional | 05/23/1989SE |
| K890448 | Light Source, Endoscop, Xenon ArcFFS · Traditional | 05/08/1989SE |
| K863246 | MiraliteHQF · Traditional | 10/31/1986SE |
| K863591 | Endophotocoagulation ProbeHQF · Traditional | 10/10/1986SE |
| K855105 | Simmons ShellHQT · Traditional | 03/31/1986SE |
Questions and answers
When was Schepens-Yoshida Video Binocular Indirect Ophthalmscope cleared by the FDA?
Schepens-Yoshida Video Binocular Indirect Ophthalmscope (K951728) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 706 days after the submission was received.
What is the product code of K951728?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.