Oct-Opthalmoscope
FDA 510(k) K042885 · Ophthalmic Technologies, Inc.
510(k) numberK042885
Submission
- Device name
- Oct-Opthalmoscope
- Applicant
- Ophthalmic Technologies, Inc.
Hasbrouck, NJ, US - Received
- October 19, 2004
- Decision date
- January 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K031391 | HF Module with TransducersIYO · Special | 06/20/2003SE |
| K030770 | Oti Scan with TransducersIYO · Special | 03/27/2003SE |
| K024114 | A-Scan 100IYO · Special | 01/10/2003SE |
| K990064 | Di-Rhex Ophthalmic Diathermy SystemHQR · Traditional | 04/04/1999SE |
| K974522 | 3D I-ScanIYO · Traditional | 02/25/1998SE |
| K971679 | I-Scope Ophthalmic EndoscopeMPA · Traditional | 06/25/1997SE |
| K960622 | I-ScanIYO · Traditional | 05/13/1996SE |
| K954263 | Xe-LiteFTD · Traditional | 10/18/1995SESD |
Questions and answers
When was Oct-Opthalmoscope cleared by the FDA?
Oct-Opthalmoscope (K042885) received a 510(k) decision of Substantially Equivalent on January 21, 2005, 94 days after the submission was received.
What is the product code of K042885?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.