XERF
FDA 510(k) clearance K251327 · decided 2025-08-11
Clearance details
- K-number
- K251327
- Device name
- XERF
- Applicant
- Lutronic Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-04-30
- Decision date
- 2025-08-11
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Deogyang-Gu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| XERF EFFECTOR 60. Electrosurgical unit. recall (Z-0146-2026) | Lutronic Corporation | 2025-10-14 |