510(k) K043068
K043068 is an FDA 510(k) premarket notification submitted by Electro-Optical Sciences, Inc. for the device "DIFOTI USB 2.0 SYSTEM". The FDA issued a decision of Substantially Equivalent on December 29, 2004. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Electro-Optical Sciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2004
- Date Received
- November 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type