LUTRONIC GENIUS
FDA 510(k) clearance K253484 · decided 2026-06-29
Clearance details
- K-number
- K253484
- Device name
- LUTRONIC GENIUS
- Applicant
- Cynosure Lutronic Technology Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-10-17
- Decision date
- 2026-06-29
- Days to decision
- 255 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
- Goyang Gyeonggi, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.