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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K843594
Device Name AIRVIT MODEL 8500
Applicant
Lasermed Corp.
P.O. Box 8047
Newport Beach,  CA  92658
Applicant Contact RAUL A SOLIS
Correspondent
Lasermed Corp.
P.O. Box 8047
Newport Beach,  CA  92658
Correspondent Contact RAUL A SOLIS
Regulation Number886.4150
Classification Product Code
HQE  
Date Received09/12/1984
Decision Date 04/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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