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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K211605
Device Name Dual Switch
Applicant
Laser Engineering, Inc.
475 Metroplex Dr. Suite 401
Nashville,  TN  37211
Applicant Contact Laurie Dobbs
Correspondent
Laser Engineering, Inc.
475 Metroplex Dr. Suite 401
Nashville,  TN  37211
Correspondent Contact Laurie Dobbs
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/25/2021
Decision Date 09/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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