FDA 510(k)

LUTRONIC GENIUS

Номер K: K253484 · 2026-06-29

ЗаявительCynosure Lutronic Technology Corporation

Дата решения2026-06-29

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

LUTRONIC GENIUS is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure Lutronic Technology Corporation. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253484. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the LUTRONIC GENIUS?

LUTRONIC GENIUS is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Cynosure Lutronic Technology Corporation. The 510(k) number is K253484.

When did LUTRONIC GENIUS receive FDA 510(k) clearance?

LUTRONIC GENIUS received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253484.

Who is the listed applicant for LUTRONIC GENIUS?

The FDA 510(k) record lists Cynosure Lutronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUTRONIC GENIUS?

The FDA product code for LUTRONIC GENIUS is GEI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Официальный источник

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