FDA 510(k) Application Details - K990075

Device Classification Name Laser, Ophthalmic

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510(K) Number K990075
Device Name Laser, Ophthalmic
Applicant LIGHT-MED (USA), INC.
110P VIA ESTRADA
LAGUNA HILLS, CA 92653 US
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Contact THOMAS V KEELEY
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Regulation Number 886.4390

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Classification Product Code HQF
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Date Received 01/11/1999
Decision Date 03/30/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K990075


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