SPECTRA LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K103455
Device Name SPECTRA LASER SYSTEM
Applicant
LUTRONIC CORPORATION
51 everett drive,
unit a-50
princeton junction, 
NJ 
08550

Applicant Contact jhung won vojir
Correspondent
LUTRONIC CORPORATION
51 everett drive,
unit a-50
princeton junction, 
NJ 
08550

Correspodent Contact jhung won vojir
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/23/2010
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No