510(k) Premarket Notification

• Device Classification Name: activator, ultraviolet, for polymerization
• 510(K) Number: K024374
• Device Name: RMO PLASMA CURING LIGHT
• Applicant: LOKKI LASERS MEDICAUX; 344 annabelle point rd.; centerville, MA 02632 2402
• Contact: hillard w welch
• Regulation Number: 872.6070
• Classification Product Code: EBZ
• Date Received: 12/31/2002
• Decision Date: 03/10/2003
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Dental
• Review Advisory Committee: Dental
• statement: statement
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No