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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 K933918
Device Name SHARPLAN MODEL 1080S CO2 SURGICAL LASER
Applicant
Sharplan Lasers, Inc.
One Pearl Ct.
Allendale,  NJ  07401
Applicant Contact DOUGLASS MEAD
Correspondent
Sharplan Lasers, Inc.
One Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact DOUGLASS MEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/10/1993
Decision Date 08/25/1994
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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