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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 K932272
Device Name CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS
Applicant
Lc Ent.
1111 St. Gregory St.
Cincinnati,  OH  45202
Correspondent
Lc Ent.
1111 St. Gregory St.
Cincinnati,  OH  45202
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
GCJ  
Date Received05/12/1993
Decision Date 10/12/1993
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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