Optyse Ophthalmoscope
FDA 510(k) K061278 · Ophthalmos , Ltd.
510(k) numberK061278
Submission
- Device name
- Optyse Ophthalmoscope
- Applicant
- Ophthalmos , Ltd.
Ickleton, Cambridge, GB - Received
- May 8, 2006
- Decision date
- May 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HLJ – Ophthalmoscope, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Other 510(k)s with product code HLJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180HLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 05/18/2015SE |
| K142837 | Heine Sigma 250 & Heine Sigma 250 M2HLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 01/29/2015SE |
| K131959 | Heine Mini 3000(R) OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 03/07/2014SE |
| K131961 | Heine Beta 200(R) OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 12/04/2013SE |
| K131719 | Ophthalmoscopes Diagnostic Instrument KitsHLJ · Traditional | Medical Devices (Pvt) , Ltd. | 10/30/2013SE |
| K123587 | Heine Mini 3000 LED OphthalmoscopeHLJ · Abbreviated | Heine Optotechnik GmbH & Co. KG | 03/22/2013SE |
| K093495 | Otoscope and Ophthalmoscope Diagnostic Instrument KitsHLJ · Traditional | American Diagnostic Corp. | 11/19/2010SE |
| K070270 | Piccolight E50,PICCOLIGHT E56,EUROLIGHT E10, Eurolight E30, and Eurolight E36HLJ · Traditional | Kirchner & Wilhelm GmbH + Co.Kg | 11/05/2007SE |
| K052599 | 66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25AHLJ · Traditional | Suzhou 66 Vision Tech Co., Ltd. | 11/07/2006SE |
| K053425 | Precision Optics Corporation Video Ophthalmoscope, Model 2500-VOSHLJ · Traditional | Precision Optics Corp. | 01/09/2006SE |
Questions and answers
When was Optyse Ophthalmoscope cleared by the FDA?
Optyse Ophthalmoscope (K061278) received a 510(k) decision of Substantially Equivalent on May 16, 2006, 8 days after the submission was received.
What is the product code of K061278?
The FDA product code is HLJ – Ophthalmoscope, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.