OMNILUX CLEAR-U


Device Classification Name

over-the-counter powered light based laser for acne

510(k) Number K081307
Device Name OMNILUX CLEAR-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
OLP  
Date Received 05/08/2008
Decision Date 01/16/2009
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