Parkone
FDA 510(k) K073508 · Oculus Optikgerate GmbH
510(k) numberK073508
Submission
- Device name
- Parkone
- Applicant
- Oculus Optikgerate GmbH
Wetzlar, DE - Received
- December 13, 2007
- Decision date
- September 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXK – Device, Analysis, Anterior Segment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
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| K182659 | Galilei G6 Lens ProfessionalMXK · Traditional | Sis Ag, Surgical Instrument Systems | 07/25/2019SE |
| K191051 | ArgosMXK · Traditional | Santec Corporation | 05/16/2019SE |
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Questions and answers
When was Parkone cleared by the FDA?
Parkone (K073508) received a 510(k) decision of Substantially Equivalent on September 11, 2008, 273 days after the submission was received.
What is the product code of K073508?
The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.