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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 K914827
Device Name LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION
Applicant
Laser Photonics, Inc.
12351 Research Pkwy.
Orlando,  FL  32826
Applicant Contact ROBERT J ANSELMO
Correspondent
Laser Photonics, Inc.
12351 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact ROBERT J ANSELMO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/22/1991
Decision Date 03/27/1992
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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