510(k) K130565
K130565 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "SPECULAR MICROSCOPE CEM-530". The FDA issued a decision of Substantially Equivalent on November 27, 2013. The device falls under product code NQE (Microscope, Specular), a Class II device regulated under 21 CFR 886.1850. Nidek Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2013
- Date Received
- March 4, 2013
- 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.