PROLITE III TOWER AND PR AND HR HANDPIECE


Device Classification Name

powered laser surgical instrument

510(k) Number K081095
Device Name PROLITE III TOWER AND PR AND HR HANDPIECE
Applicant
QUANTEL S.A.
601 haggerty lane
bozeman, 
MT 
59715

Applicant Contact michael johnson
Correspondent
QUANTEL S.A.
601 haggerty lane
bozeman, 
MT 
59715

Correspodent Contact michael johnson
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/17/2008
Decision Date 12/12/2008
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