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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 K925178
Device Name PEGASUS
Applicant
Premier Laser Systems, Inc.
#3 Morgan
Irvine,  CA  92618
Applicant Contact JUDY E MAZZA
Correspondent
Premier Laser Systems, Inc.
#3 Morgan
Irvine,  CA  92618
Correspondent Contact JUDY E MAZZA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/14/1992
Decision Date 03/14/1994
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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