OMNILUX NEW-U


Device Classification Name

light based over the counter wrinkle reduction

510(k) Number K072459
Device Name OMNILUX NEW-U
Applicant
PHOTO THERAPEUTICS, INC.
2720 loker avenue west
carlsbad, 
CA 
92010

Applicant Contact sue darcy
Correspondent
PHOTO THERAPEUTICS, INC.
2720 loker avenue west
carlsbad, 
CA 
92010

Correspodent Contact sue darcy
Regulation Number 878.4810
Classification Product Code
OHS  
Date Received 08/31/2007
Decision Date 03/03/2008
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