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半导体激光治疗仪Vectus Laser System国械注进20173091591

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半导体激光治疗仪Vectus Laser System is a Energy-based device product (Class III device), registered by Cynosure, LLC. Linked registrations: China 国械注进20173091591. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderCynosure, LLC
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

半导体激光治疗仪Vectus Laser System

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20173091591
Registrant
Cynosure, LLC 美国赛诺秀公司
China agent
苏州赛诺秀医疗器械有限公司
First approval
Not obtained from an official source
This certificate issued
2021-08-06
Valid until
2026-08-05
Models and sizes
Vectus
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

AttributeTaiwan label (not China-approved)
Indications腿部静脉：本产品用于医学美容、皮肤科、一般整形外科，治疗腿部静脉; 良性色素病变：本产品用于医学美容、皮肤科、一般整形外科，治疗良性色素病变; 除毛和永久性毛发减少：本产品用于医学美容、皮肤科、一般整形外科，进行除毛和永久性毛发减少; Skintel 黑色素读取器：Skintel黑色素读取器用于检查皮肤黑色素含量，测试并设定测试点的黑色素起始能量; 血管性病变：本产品用于医学美容、皮肤科、一般整形外科，治疗血管性病变; 所有皮肤类型（含晒黑的皮肤）：这些适应症用于治疗所有皮肤类型，包括晒黑的皮肤
Contraindications原文未报告Not reported
Composition不适用N/A
Storage运送/储存：运输/储存温度：0-50°C
Shelf life原文未报告Not reported
Injection depth不适用N/A
Recommended dose不适用N/A
Duration不适用N/A
Adverse reactions原文未报告Not reported
Warnings眼睛不可直视手握把光发射端发出的光，否则会造成眼睛伤害；除治疗区外勿将光源向任何物体击发；不可将手握把对着空气发射; 本产品关闭后高压组件仍可能含有电荷，除受过训练、获授权的技术人员外，不可自行开启主机或手握把的外罩; 紧急停止按钮位于主机左侧的红色大按钮，按下可立即使系统关闭；操作人员应熟悉其位置; 勿将手握把浸于任何溶液，浸湿手握把可能对使用者与治疗对象造成危害及机器故障; 产品未使用时，确保未经授权的人员无法开启使用，将仪器钥匙取下使仪器无法运作，并将仪器放在上锁的地方; 不可在易燃性液体（如酒精）或易燃性麻醉剂（如乙醚）旁操作本系统；安全起见，将可燃物品（如纱布及棉棒）以水或食盐水沾湿; 使用氧气应更加特别小心，氧的存在可加速任何可燃物质的燃烧; 治疗室内人员，包括医生、工作人员以及正在接受治疗的人，皆需戴上防护790-830 nm波长范围、光密度至少7的雷射防护眼镜
preparation不适用N/A
storage after preparation不适用N/A

Each cell is extracted from that jurisdiction's label; click the number for the original passage. “—” means nothing has been extracted for it yet, not that the label is silent. Columns other than China reflect what was approved there, for reference only, not what China approved. 24 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20173091591 change

    官网变更：“注册人名称：美国 赛诺秀公司（Cynosure, Inc.);”变更为“注册人名称：Cynosure, LLC 美国赛诺秀公司;”。

  2. CN

    国械注进20173091591 change

    “注册人名称：美国 赛诺秀公司（Cynosure, Inc.);”变更为“注册人名称：Cynosure, LLC 美国赛诺秀公司;”。

  3. CN

    国械注进20173091591 this certificate issued

    Issue date of this certificate, not the first approval

  4. CN

    国械注进20173091591 change

    官网变更：原注册证生产地址由“美国麻省01886威斯福德卡丽斯路5号 5 Carlisle Road, Westford, MA 01886” 变更为“127 Hartwell St. West Boylston, MA USA 01583； 5 Carlisle RD, Wes…

  5. CN

    国械注进20173091591 change

    原注册证生产地址由“美国麻省01886威斯福德卡丽斯路5号 5 Carlisle Road, Westford, MA 01886” 变更为“127 Hartwell St. West Boylston, MA USA 01583； 5 Carlisle RD, Westford…

  6. CN

    国械注进20173091591 valid until

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

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Recent changes

5
  • 国械注进20173091591: 官网变更：原注册证生产地址由“美国麻省01886威斯福德卡丽斯路5号 5 Carlisle Road, Westford, MA 01886” 变更为“127 …2021-11-22
  • 国械注进20173091591: 原注册证生产地址由“美国麻省01886威斯福德卡丽斯路5号 5 Carlisle Road, Westford, MA 01886” 变更为“127 Hartw…2021-11-22
  • 国械注进20173091591: certificate issued2021-08-06
  • 国械注进20173091591: 官网变更：“注册人名称：美国 赛诺秀公司（Cynosure, Inc.);”变更为“注册人名称：Cynosure, LLC 美国赛诺秀公司;”。2019-08-08
  • 国械注进20173091591: “注册人名称：美国 赛诺秀公司（Cynosure, Inc.);”变更为“注册人名称：Cynosure, LLC 美国赛诺秀公司;”。2019-08-08

Sources

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