CURASYS 2 (EMDN0003)
FDA 510(k) clearance K253199 · decided 2026-06-23
Clearance details
- K-number
- K253199
- Device name
- CURASYS 2 (EMDN0003)
- Applicant
- CG Bio Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-06-23
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.