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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K930210
Device Name ACL-5500
Applicant
Ilt Systems, Inc.
3828 S. Main
Salt Lake City,  UT  84115
Applicant Contact ROBERT S HEAD
Correspondent
Ilt Systems, Inc.
3828 S. Main
Salt Lake City,  UT  84115
Correspondent Contact ROBERT S HEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/15/1993
Decision Date 04/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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