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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 K921298
Device Name MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER
Applicant
Cj Laser Corp.
3035 Dryden Rd.
Dayton,  OH  45439
Applicant Contact CEM GOKAY
Correspondent
Cj Laser Corp.
3035 Dryden Rd.
Dayton,  OH  45439
Correspondent Contact CEM GOKAY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/17/1992
Decision Date 07/02/1992
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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