Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

FSYX Ocular Pressure Adjusting Pump

Número K: K252455 · 2026-04-30

RequerenteBalance Ophthalmics, Inc.
Data da decisão2026-04-30
Código do produtoQQJ
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do dispositivo

FSYX Ocular Pressure Adjusting Pump is the device name listed in this FDA 510(k) record. The listed applicant is Balance Ophthalmics, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K252455. The device is classified under product code QQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FSYX Ocular Pressure Adjusting Pump?

FSYX Ocular Pressure Adjusting Pump is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Balance Ophthalmics, Inc.. The 510(k) number is K252455.

When did FSYX Ocular Pressure Adjusting Pump receive FDA 510(k) clearance?

FSYX Ocular Pressure Adjusting Pump received FDA 510(k) clearance on 2026-04-30, under 510(k) number K252455.

Who is the listed applicant for FSYX Ocular Pressure Adjusting Pump?

The FDA 510(k) record lists Balance Ophthalmics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FSYX Ocular Pressure Adjusting Pump?

The FDA product code for FSYX Ocular Pressure Adjusting Pump is QQJ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑