510(k) K171313
K171313 is an FDA 510(k) premarket notification submitted by Tomey Corporation for the device "EM-4000 Specular Microscope". The FDA issued a decision of Substantially Equivalent on January 19, 2018. The device falls under product code NQE (Microscope, Specular), a Class II device regulated under 21 CFR 886.1850. Tomey Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2018
- Date Received
- May 4, 2017
- 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.