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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 K904402
Device Name NIDEK INC. MODEL AC-2000 DERM
Applicant
Nidek, Inc.
Crc Associates
25422 Trabuco Rd.#105-253
El Toro,  CA  92630
Applicant Contact JANET MCCOMB
Correspondent
Nidek, Inc.
Crc Associates
25422 Trabuco Rd.#105-253
El Toro,  CA  92630
Correspondent Contact JANET MCCOMB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/1990
Decision Date 12/07/1990
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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