CERALAS 980NM DIODE LASER FAMILY


Device Classification Name

powered laser surgical instrument

510(k) Number K112324
Device Name CERALAS 980NM DIODE LASER FAMILY
Applicant
BIOLITEC MEDICAL DEVICES, INC
1349 main road
grandville, 
MA 
01034

Applicant Contact harry hayes
Correspondent
BIOLITEC MEDICAL DEVICES, INC
1349 main road
grandville, 
MA 
01034

Correspodent Contact harry hayes
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/12/2011
Decision Date 09/06/2011
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