Legend X Platform
FDA 510(k) clearance K252576 · decided 2025-09-12
Clearance details
- K-number
- K252576
- Device name
- Legend X Platform
- Applicant
- Pollogen, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-14
- Decision date
- 2025-09-12
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tel Aviv, IL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.