CERALAS D 980NM DIODE LASER, MODELS D15 AND D25


Device Classification Name

powered laser surgical instrument

510(k) Number K072779
Device Name CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
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 09/28/2007
Decision Date 01/24/2008
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