LUTRONIC GENIUS— 510(k) K253484
Substantially EquivalentCynosure Lutronic Technology Corporation
FDA 510(k) clearance K253484 for LUTRONIC GENIUS, Substantially Equivalent on 2026-06-29. Applicant: Cynosure Lutronic Technology Corporation. Device class: 2.
Summary
LUTRONIC GENIUS from Cynosure Lutronic Technology Corporation is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the device beyond its brand name and the code name.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and the submission was a Traditional 510(k).
The applicant filed from Goyang Gyeonggi, South Korea. Review took 255 calendar days (October 17, 2025 to June 29, 2026).
Clearance details
- Applicant
- Cynosure Lutronic Technology Corporation
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goyang Gyeonggi, KR
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- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.