NATURALASE CO2 LASER SYSTEM


Device Classification Name

powered laser surgical instrument with microbeamfractional output

510(k) Number K110333
Device Name NATURALASE CO2 LASER SYSTEM
Applicant
FOCUS MEDICAL, LLC.
23 francis j. clarke circle
bethel, 
CT 
06801

Applicant Contact john lee
Correspondent
FOCUS MEDICAL, LLC.
23 francis j. clarke circle
bethel, 
CT 
06801

Correspodent Contact john lee
Regulation Number 878.4810
Classification Product Code
ONG  
Date Received 02/03/2011
Decision Date 04/12/2012
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