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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K973193
Device Name LUXSCOPE
Applicant
LUXTEC CORP.
45 PONTIAC RD.
NEWTON,  MA  02168
Applicant Contact JOSEPH RESS
Correspondent
LUXTEC CORP.
45 PONTIAC RD.
NEWTON,  MA  02168
Correspondent Contact JOSEPH RESS
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/25/1997
Decision Date 11/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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