免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Erchonia DPN 激光 (型号# EVRL)

K号: K251903 · 2026-02-19

决定日期2026-02-19
产品代码NHN
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Erchonia DPN Laser (Model# EVRL) is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K251903. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Erchonia DPN Laser (Model# EVRL)?

Erchonia DPN Laser (Model# EVRL) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Erchonia Corporation. The 510(k) number is K251903.

When did Erchonia DPN Laser (Model# EVRL) receive FDA 510(k) clearance?

Erchonia DPN Laser (Model# EVRL) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K251903.

Who is the listed applicant for Erchonia DPN Laser (Model# EVRL)?

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

What is the FDA product code for Erchonia DPN Laser (Model# EVRL)?

The FDA product code for Erchonia DPN Laser (Model# EVRL) is NHN.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

列明Erchonia Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

查看所有 17 个设备 →

相关器械(代码:NHN)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

↑