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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
510(k) Number K190572
Device Name Erchonia FX-635
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact Steven Shanks
Regulatory Insight, Inc.
650 Atlantis Rd.
Melbourne,  FL  32904
Correspondent Contact Steven Shanks
Regulation Number890.5500
Classification Product Code
Date Received03/06/2019
Decision Date 06/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No