MX-7000 MICROXEL


Device Classification Name

powered laser surgical instrument with microbeamfractional output

510(k) Number K111831
Device Name MX-7000 MICROXEL
Applicant
BIO-MED U.S.A., INC.
111 ellison st.
paterson, 
NJ 
07505

Applicant Contact young chi
Correspondent
BIO-MED U.S.A., INC.
111 ellison st.
paterson, 
NJ 
07505

Correspodent Contact young chi
Regulation Number 878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received 06/28/2011
Decision Date 12/19/2011
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