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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K855093
Device Name MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
Applicant
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Regulation Number884.4550
Classification Product Code
HHR  
Date Received12/20/1985
Decision Date 02/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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