XTRAC ULTRA 2, MODEL AL10000


Device Classification Name

powered laser surgical instrument

510(k) Number K073659
Device Name XTRAC ULTRA 2, MODEL AL10000
Applicant
PHOTO MEDEX, INC.
2375 camino vida roble,
suite b
carlsbad, 
CA 
92011

Applicant Contact jeff levatter
Correspondent
PHOTO MEDEX, INC.
2375 camino vida roble,
suite b
carlsbad, 
CA 
92011

Correspodent Contact jeff levatter
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/26/2007
Decision Date 03/05/2008
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