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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 K964751
Device Name CERALAS DIODE LASER SYSTEM (CERALAS D2)
Applicant
Ceram Optec, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Ceram Optec, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received11/26/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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