Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

PMA de la FDA

Light adjustable lens (LAL) and light delivery device (LDD)

Número de PMA: P160055 · 2026-09-03

SolicitanteRxsight, Inc.
Fecha de decisión2026-09-03
Número PMAP160055
Código de productoPZK
Clase del dispositivoClase 3
Especialidad médicaO
Número de regulación21 CFR 8
Comité asesorOP

Resumen del dispositivo

Light adjustable lens (LAL) and light delivery device (LDD) is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2026-09-03. The device is classified under product code PZK. It was reviewed by the OP advisory panel.

Preguntas frecuentes

What is the Light adjustable lens (LAL) and light delivery device (LDD)?

Light adjustable lens (LAL) and light delivery device (LDD) is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Rxsight, Inc..

When did Light adjustable lens (LAL) and light delivery device (LDD) receive FDA 510(k) clearance?

The clearance date for Light adjustable lens (LAL) and light delivery device (LDD) can be found in the official FDA records.

Who is the listed applicant for Light adjustable lens (LAL) and light delivery device (LDD)?

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

What is the FDA product code for Light adjustable lens (LAL) and light delivery device (LDD)?

The FDA product code for Light adjustable lens (LAL) and light delivery device (LDD) is PZK.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑