FDA 510(k)

FEMTO LDV Z8 Femtosecond Surgical Laser

Número K: K213559 · 2022-04-21

RequerenteSie Ag,Surgical Instrument Engineering

Data da decisão2022-04-21

Código do produtoOOE

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

FEMTO LDV Z8 Femtosecond Surgical Laser is the device name listed in this FDA 510(k) record. The listed applicant is Sie Ag,Surgical Instrument Engineering. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213559. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FEMTO LDV Z8 Femtosecond Surgical Laser?

FEMTO LDV Z8 Femtosecond Surgical Laser is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Sie Ag,Surgical Instrument Engineering. The 510(k) number is K213559.

When did FEMTO LDV Z8 Femtosecond Surgical Laser receive FDA 510(k) clearance?

FEMTO LDV Z8 Femtosecond Surgical Laser received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213559.

Who is the listed applicant for FEMTO LDV Z8 Femtosecond Surgical Laser?

The FDA 510(k) record lists Sie Ag,Surgical Instrument Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser?

The FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser is OOE.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: OOE)

K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC K220259Sistema de Tratamento de Catarata ADAPTIVO ALLYLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.