MULA (K2-A1)
FDA 510(k) clearance K240314 · decided 2024-08-21
Clearance details
- K-number
- K240314
- Device name
- MULA (K2-A1)
- Applicant
- Guangzhou Ciellulu Photoelectric Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-02
- Decision date
- 2024-08-21
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- ONF
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.