510(k) K142417
K142417 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "SP-1PSpecular Microscope". The FDA issued a decision of Substantially Equivalent on May 29, 2015. The device falls under product code NQE (Microscope, Specular), a Class II device regulated under 21 CFR 886.1850. Topcon Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2015
- Date Received
- August 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microscope, Specular
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.