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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultraviolet Radiation Disinfection Chamber Device
510(k) Number K260427
Device Name Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)
Applicant
Lumicare Medtech Co., Ltd.
Level 8, 1a, Zhongcheng Biomedical Industrial Park, #21 Linh
Shenzhen,  CN 518122
Applicant Contact Tong Liu
Correspondent
Lumicare Pty, Ltd.
Level 6, 15 Orion Rd.
Ln. Cove W.,  AU 2066
Correspondent Contact Lukas Spoegler
Classification Product Code
SCS  
Date Received02/10/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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