FOX 1-980, FOX Q-1064, FOX-Q-810


Device Classification Name

powered laser surgical instrument

510(k) Number K073322
Device Name FOX 1-980, FOX Q-1064, FOX-Q-810
Applicant
A.R.C. LASER GMBH
3202 tower oaks blvd
suite 300
rockville, 
MD 
20852

Applicant Contact kirsten h paulson
Correspondent
A.R.C. LASER GMBH
3202 tower oaks blvd
suite 300
rockville, 
MD 
20852

Correspodent Contact kirsten h paulson
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/26/2007
Decision Date 02/22/2008
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