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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K884694
Device Name MQL 20 ND:YAG OPHTHALMIC LASER
Applicant
California Laboratories, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Applicant Contact KENNETH R MICHAEL
Correspondent
California Laboratories, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Correspondent Contact KENNETH R MICHAEL
Regulation Number886.4390
Classification Product Code
LQJ  
Date Received11/09/1988
Decision Date 11/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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