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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K914484
Device Name LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
Applicant
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact GREGORY R MCARTHUR
Correspondent
Hgm Medical Laser Systems, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact GREGORY R MCARTHUR
Regulation Number886.1570
Classification Product Code
HLI  
Date Received10/08/1991
Decision Date 01/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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