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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
510(k) Number K901605
Device Name PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
Applicant
Phoenix Laser Systems, Inc.
205 25th Ave. N.
St.Petersburg,  FL  33704
Applicant Contact JOANN R SCHULZ
Correspondent
Phoenix Laser Systems, Inc.
205 25th Ave. N.
St.Petersburg,  FL  33704
Correspondent Contact JOANN R SCHULZ
Regulation Number886.4392
Classification Product Code
LXS  
Date Received04/05/1990
Decision Date 12/13/1990
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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