Lumicare (3 models)— 510(k) K260427
Substantially EquivalentLumicare Medtech Co., Ltd.
FDA 510(k) clearance K260427 for Lumicare (3 models), Substantially Equivalent on 2026-10-29. Applicant: Lumicare Medtech Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)
- Applicant
- Lumicare Medtech Co., Ltd.
- Product code
- Product code SCS
- Device class
- Class 2
- Regulation
- 21 CFR 880.6511
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code SCS
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