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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 K933140
Device Name RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM
Applicant
Laser Photonics, Inc.
12351 Research Pkwy.
Orlando,  FL  32826
Applicant Contact CLEMENT DARROW
Correspondent
Laser Photonics, Inc.
12351 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact CLEMENT DARROW
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/28/1993
Decision Date 03/02/1994
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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