ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE


Device Classification Name

powered laser surgical instrument

510(k) Number K112166
Device Name ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
Applicant
W AND R INVESTMENTS DBA LASER ENGINEERING
113 cedar street
milford, 
MA 
01757

Applicant Contact robert i rudko
Correspondent
W AND R INVESTMENTS DBA LASER ENGINEERING
113 cedar street
milford, 
MA 
01757

Correspodent Contact robert i rudko
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/28/2011
Decision Date 10/21/2011
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