FDA Cleared
New Device
Pathway: 510K
Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)
Applicant:
Lumicare Medtech Co., Ltd.
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
SCS
Review Panel:
General Hospital
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-02-10
Decision Date:
2026-10-29
Total Review Duration:
261 calendar days (261 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Tong Liu
Role: SUBMITTER_CONTACT
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