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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Light, Soft Tissue Detector
510(k) Number K070523
Device Name MODIFICATION TO: VELSCOPE
Applicant
Led Dental, Inc.
#201-15047 Marine Dr.
White Rock, British Columbia,  CA V4B 1C5
Applicant Contact DAVID C MORGAN, PHD
Correspondent
Led Dental, Inc.
#201-15047 Marine Dr.
White Rock, British Columbia,  CA V4B 1C5
Correspondent Contact DAVID C MORGAN, PHD
Regulation Number872.6350
Classification Product Code
NXV  
Date Received02/23/2007
Decision Date 04/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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