510(k) K152311
K152311 is an FDA 510(k) premarket notification submitted by Oculus Optikgerate GmbH for the device "Pentacam AXL". The FDA issued a decision of Substantially Equivalent on January 20, 2016. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Oculus Optikgerate GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2016
- Date Received
- August 14, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Analysis, Anterior Segment
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type