CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT


Device Classification Name

powered laser surgical instrument

510(k) Number K030700
Device Name CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
Applicant
BIOLITEC, INC.
555 thirteenth st., nw
washington, 
DC 
20004 -1109

Applicant Contact jonathan s kahan
Correspondent
BIOLITEC, INC.
555 thirteenth st., nw
washington, 
DC 
20004 -1109

Correspodent Contact jonathan s kahan
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 03/06/2003
Decision Date 06/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No