CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25


Device Classification Name

powered laser surgical instrument

510(k) Number K024088
Device Name CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
Original Applicant
BIOLITEC, INC.
555 thirteenth st., nw
washington, 
DC 
20004 -5910

Original Contact jonathan s kahan
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/11/2002
Decision Date 01/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No