Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
FDA 510(k) clearance K261775 · decided 2026-07-21
Clearance details
- K-number
- K261775
- Device name
- Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-05-29
- Decision date
- 2026-07-21
- Days to decision
- 53 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Xuzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.