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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 K173067
Device Name LightForce LTS Model 1000, 1500, 2500, and 4000
Applicant
Litecure, LLC
250 Corporate Blvd.
Suite B
Newark,  DE  19702
Applicant Contact Eric Rock
Correspondent
Certified Compliance Solutions, Inc.
11665 Avena Pl. Suite 203
San Diego,  CA  92128
Correspondent Contact Curtis M. Egan
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ILY   PDZ  
Date Received09/29/2017
Decision Date 02/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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