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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827819
Device Name LASER PHOTOCOAGULATOR
Applicant
American Laser Corp.
2860 Wilderness Pl.
Boulder,  CO  80301
Correspondent
American Laser Corp.
2860 Wilderness Pl.
Boulder,  CO  80301
Date Received10/19/1982
Decision Date 01/07/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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