Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
FDA 510(k) clearance K252745 · decided 2025-12-12
Clearance details
- K-number
- K252745
- Device name
- Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- Applicant
- Micro-Energy Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-29
- Decision date
- 2025-12-12
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.