510(k) K102167
K102167 is an FDA 510(k) premarket notification submitted by Fiberoptics Technology, Inc. for the device "LO-50 LED LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on August 17, 2010. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Fiberoptics Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2010
- Date Received
- August 2, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Led Light Source
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals