PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K073477
Device Name PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
Applicant
PHOTONOVA OFSWEDEN AB
908 stetson street
woodland, 
CA 
95776

Applicant Contact connie hoy
Correspondent
PHOTONOVA OFSWEDEN AB
908 stetson street
woodland, 
CA 
95776

Correspodent Contact connie hoy
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/11/2007
Decision Date 05/09/2008
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