510(k) clearance
Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)
- 510(k) number
- K260427
- Applicant
- Lumicare Medtech Co., Ltd.
- Decision date
- Oct 29, 2026
- Date received
- Feb 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SCS
- Device type
- Ultraviolet Radiation Disinfection Chamber Device
- Device class
- Class II
- Regulation
- 21 CFR 880.6511
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN