Heine Omega 500
FDA 510(k) K123316 · Heine Optotechnik GmbH & Co. KG
510(k) numberK123316
Submission
- Device name
- Heine Omega 500
- Applicant
- Heine Optotechnik GmbH & Co. KG
Herrsching, DE - Received
- October 25, 2012
- Decision date
- February 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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| K120238 | Rtvue XR OctHLI · Special | Optovue, Inc. | 04/03/2012SE |
More from Optovue, Inc.
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| K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180HLJ · Abbreviated | 05/18/2015SE |
| K142837 | Heine Sigma 250 & Heine Sigma 250 M2HLJ · Abbreviated | 01/29/2015SE |
| K131959 | Heine Mini 3000(R) OphthalmoscopeHLJ · Abbreviated | 03/07/2014SE |
| K131961 | Heine Beta 200(R) OphthalmoscopeHLJ · Abbreviated | 12/04/2013SE |
| K123587 | Heine Mini 3000 LED OphthalmoscopeHLJ · Abbreviated | 03/22/2013SE |
| K101892 | Heine Gamma G7; Heine Gamma G5, Heine Gamma GP, Heine Gamma GST, Heine Gamma XXL LF…DXQ · Traditional | 08/27/2010SE |
Questions and answers
When was Heine Omega 500 cleared by the FDA?
Heine Omega 500 (K123316) received a 510(k) decision of Substantially Equivalent on February 26, 2013, 124 days after the submission was received.
What is the product code of K123316?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.