BIOSYAG MEDICAL SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K080374
Device Name BIOSYAG MEDICAL SYSTEM
Applicant
BIOS S.R.L.
4235 e. broadway
long beach, 
CA 
90803

Applicant Contact alessandro franchi
Correspondent
BIOS S.R.L.
4235 e. broadway
long beach, 
CA 
90803

Correspodent Contact alessandro franchi
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/12/2008
Decision Date 05/15/2008
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