Vantage Indirect Ophthalmoscope
FDA 510(k) K060822 · Keeler Instruments, Inc.
510(k) numberK060822
Submission
- Device name
- Vantage Indirect Ophthalmoscope
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- March 27, 2006
- Decision date
- May 23, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
| K970029 | Keeler Spectra Indirect OphthalmoscopeHLJ · Traditional | 04/02/1997SE |
Questions and answers
When was Vantage Indirect Ophthalmoscope cleared by the FDA?
Vantage Indirect Ophthalmoscope (K060822) received a 510(k) decision of Substantially Equivalent on May 23, 2006, 57 days after the submission was received.
What is the product code of K060822?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.