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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 K001772
Device Name LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
Applicant
Taracan Pty. , Ltd.
258 Halifax St.
Adelaide, South Australia,  AU 5000
Applicant Contact KEITH DEGENHARDT
Correspondent
Taracan Pty. , Ltd.
258 Halifax St.
Adelaide, South Australia,  AU 5000
Correspondent Contact KEITH DEGENHARDT
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received06/12/2000
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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