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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 K862456
Device Name ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
Applicant
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Applicant Contact CHARLES ROSE
Correspondent
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Correspondent Contact CHARLES ROSE
Regulation Number884.4550
Classification Product Code
HHR  
Date Received06/27/1986
Decision Date 08/12/1986
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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