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)

Stellaris Elite™视觉增强系统(BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

K号: K252052 · 2026-03-25

申请人Bausch and Lomb, Incorporated
决定日期2026-03-25
产品代码HQC
咨询委员会OP 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

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch and Lomb, Incorporated. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252052. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)?

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Bausch and Lomb, Incorporated. The 510(k) number is K252052.

When did Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) receive FDA 510(k) clearance?

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252052.

Who is the listed applicant for Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)?

The FDA 510(k) record lists Bausch and Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)?

The FDA product code for Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is HQC.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Bausch and Lomb, Incorporated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。

K242389EyeGility™ Inserter for Preloaded enVista IOLsK240169Stellaris Elite视觉增强系统(BL11145, BL14455, BL15455)K220613Bausch + Lomb (kalifilcon A) 软性（亲水性）隐形眼镜，Bausch + Lomb (kalifilcon A) 软性（亲水性）散光隐形眼镜，以及，Bausch + Lomb (kalifilcon A) 软性（亲水性）老花隐形眼镜K222541Bausch + Lomb 无防腐剂润滑和湿润滴眼液K202932ABT12 多功能溶液K210975Bausch + Lomb (kalifilcon A) 软性（亲水性）老花隐形眼镜

查看所有 17 个设备 →

相关器械（代码：HQC）

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。

K261264Stellaris Elite™视觉增强系统；后部和联合手术包：23号后部Elite™包(SE5423)；23号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5423B)；25号后部Elite™包(SE5425)；25号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5425B)；27号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5427B)；23号双刀片™+玻璃体切割器后部Stellaris Elite™包(SE5423BB+)Bausch and LombK250501System SophiThis AGK243395MICOR 700 自动 I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 系统 (N/A)；MICOR 700 驱动器 (FG-50631)；MICOR 700 提取器 (FG-50621)；MICOR 700 视网膜剪刀 (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite视觉增强系统(BL11145, BL14455, BL15455)Bausch and Lomb, IncorporatedK233398Faros外科系统Oertli Instrumente AG

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。

↑