510(k) K112880
K112880 is an FDA 510(k) premarket notification submitted by Freedom Meditech, Inc. for the device "CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE". The FDA issued a decision of Substantially Equivalent on January 31, 2013. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2013
- Date Received
- September 30, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmoscope, Laser, Scanning
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type