Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
FDA 510(k) clearance K243030 · decided 2024-10-25
Clearance details
- K-number
- K243030
- Device name
- Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
- Applicant
- Ulike Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-27
- Decision date
- 2024-10-25
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- OHT
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.