66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
FDA 510(k) K052599 · Suzhou 66 Vision Tech Co., Ltd.
510(k) numberK052599
Submission
- Device name
- 66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
- Applicant
- Suzhou 66 Vision Tech Co., Ltd.
Shanghai, CN - Received
- September 21, 2005
- Decision date
- November 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K061278 | Optyse OphthalmoscopeHLJ · Abbreviated | Ophthalmos , Ltd. | 05/16/2006SE |
| K053425 | Precision Optics Corporation Video Ophthalmoscope, Model 2500-VOSHLJ · Traditional | Precision Optics Corp. | 01/09/2006SE |
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Questions and answers
When was 66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A cleared by the FDA?
66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A (K052599) received a 510(k) decision of Substantially Equivalent on November 7, 2006, 412 days after the submission was received.
What is the product code of K052599?
The FDA product code is HLJ – Ophthalmoscope, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.