OMNILUX RED


Device Classification Name

powered laser surgical instrument

510(k) Number K030426
Device Name OMNILUX RED
Applicant
PHOTO THERAPEUTICS LIMITED
5 timber ln.
north reading, 
MA 
01864

Applicant Contact maureen o’connell
Correspondent
PHOTO THERAPEUTICS LIMITED
5 timber ln.
north reading, 
MA 
01864

Correspodent Contact maureen o’connell
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/10/2003
Decision Date 07/17/2003
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