510(k) K002566
K002566 is an FDA 510(k) premarket notification submitted by Lumalite, Inc. for the device "LUMALITE CURE LIGHT, MODEL 2100". The FDA issued a decision of Substantially Equivalent on Oct 19, 2000. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Lumalite, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 2000
- Date Received
- Aug 17, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type
- 510(k)