TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K072995
Device Name TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
Applicant
LUMEN DEVELOPMENT AND MANUFACTURING, INC.
532 west 8360 south
sandy, 
UT 
84070

Applicant Contact calvin d ostler
Correspondent
LUMEN DEVELOPMENT AND MANUFACTURING, INC.
532 west 8360 south
sandy, 
UT 
84070

Correspodent Contact calvin d ostler
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/23/2007
Decision Date 12/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No