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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 K961705
Device Name AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM
Applicant
Applied Optronics Corp.
111 Corporate Blvd.
Bldg. J
South Plainfield,  NJ  07080
Applicant Contact DOUGLASS MEAD
Correspondent
Applied Optronics Corp.
111 Corporate Blvd.
Bldg. J
South Plainfield,  NJ  07080
Correspondent Contact DOUGLASS MEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/02/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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