15W CERALAS D 1470NM DIODE LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K073063
Device Name 15W CERALAS D 1470NM DIODE LASER
Applicant
BIOLITEC, INC.
555 thirteenth st., nw
washington, 
DC 
20004 -5910

Applicant Contact jonathan s kahan
Correspondent
BIOLITEC, INC.
555 thirteenth st., nw
washington, 
DC 
20004 -5910

Correspodent Contact jonathan s kahan
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/30/2007
Decision Date 02/27/2008
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