308 DERMATOLOGICAL EXCIMER SYSTEM


Device Classification Name

light, ultraviolet, dermatological

510(k) Number K073066
Device Name 308 DERMATOLOGICAL EXCIMER SYSTEM
Applicant
QUANTEL MEDICAL, INC.
377 route 17
hasbrouck heights, 
NJ 
07604

Applicant Contact george myers
Correspondent
QUANTEL MEDICAL, INC.
377 route 17
hasbrouck heights, 
NJ 
07604

Correspodent Contact george myers
Regulation Number 878.4630
Classification Product Code
FTC  
Date Received 10/30/2007
Decision Date 12/26/2007
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