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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K063297
Device Name LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
Applicant
LIGHTMED CORP.
437 HILLSIDE AVENUE
BEN LOMOND,  CA  95005
Applicant Contact DENNIS DOWELL
Correspondent
LIGHTMED CORP.
437 HILLSIDE AVENUE
BEN LOMOND,  CA  95005
Correspondent Contact DENNIS DOWELL
Regulation Number886.4390
Classification Product Code
HQF  
Date Received11/01/2006
Decision Date 09/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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