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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K050216
Device Name OMNILUX REVIVE AND OMNILUX PLUS
Applicant
Photo Therapeutics Limited
Station House
Stamford New Rd.
Altrincham, Cheshire,  GB WA14 1EP
Applicant Contact STEVE HUTSON
Correspondent
Photo Therapeutics Limited
Station House
Stamford New Rd.
Altrincham, Cheshire,  GB WA14 1EP
Correspondent Contact STEVE HUTSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/31/2005
Decision Date 08/09/2005
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
Predetermined Change
Control Plan Authorized		 No
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