GEMINI SURGICAL LASER SYSTEM & ACCESSORIES


Device Classification Name

powered laser surgical instrument

510(k) Number K034011
Device Name GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
Applicant
LASERSCOPE
3070 orchard dr.
san jose, 
CA 
95134 -2011

Applicant Contact paul hardiman
Correspondent
LASERSCOPE
3070 orchard dr.
san jose, 
CA 
95134 -2011

Correspodent Contact paul hardiman
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/24/2003
Decision Date 03/30/2004
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