510(k) K053568
K053568 is an FDA 510(k) premarket notification submitted by Lumitex, Inc. for the device "BILISOFT PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 17, 2006. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Lumitex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2006
- Date Received
- December 22, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type