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脉冲染料激光治疗仪 Candela Family of Pulse Dye Laser System国械注进20173246844

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脉冲染料激光治疗仪 Candela Family of Pulse Dye Laser System is a Energy-based device product (Class III device), registered by Candela Corporation. Linked registrations: China 国械注进20173246844. Data as of 2026-10-28.

  • Regulatory classEnergy-based device · Class III device
  • HolderCandela Corporation
  • JurisdictionsCN · TW
  • Updated2026-10-28 · v1

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

Registration and basics

脉冲染料激光治疗仪 Candela Family of Pulse Dye Laser System

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20173246844 (expired)
Registrant
Candela Corporation
China agent
美中互利（北京）国际贸易有限公司
First approval
Not obtained from an official source
This certificate issued
2017-10-17
Valid until
2022-10-16
Models and sizes
Vbeam Perfecta、 Vbeam Platinum、Vbeam Aesthetica
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疤痕：治疗疤痕; 疣：治疗疣; 色素病变：治疗色素病变，如：色素斑、雀斑、晒斑; 血管病变：治疗血管病变，如：蜘蛛网状血管瘤、酒糟鼻、下肢静脉曲张、酒色斑、血管瘤、手部血管丝
Contraindications无法核实（摘录对不上原文或原件无法识别）Could not verify
Composition不适用N/A
Storage无法核实（摘录对不上原文或原件无法识别）Could not verify
Shelf life无法核实（摘录对不上原文或原件无法识别）Could not verify
Injection depth不适用N/A
Recommended dose不适用N/A
Duration不适用N/A
Adverse reactions无法核实（摘录对不上原文或原件无法识别）Could not verify
Warnings雷射房注意事项：在激光房显眼处放置适当的警告标示; 闪火危险（Flash Fire Hazards）：其他可燃物质作为初始点火的次要影响，可能与头发、纱布、氧气输送装置、麻醉气体或氧气丰富环境中的麻醉副产物有关；存在这种次要影响时可能发生烧伤; 闪火危险（Flash Fire Hazards）：氧气通过面罩、气管内管或鼻导管输送，通常在眼周、鼻部或口部附近发生泄漏；会形成氧气丰富的环境并在面部散播，氧气的瞬时局部浓度可能会大大加速燃烧; 雷射房注意事项：操作机器时，只有参与操作且受过良好训练的人员可进入; 雷射房注意事项：用不透光的物质覆盖所有的门窗，预防激光从激光房漏出; 光学安全：整个治疗过程中指派一名负责激光系统控制的人员；系统启动时确保所有人员都戴着适当的安全眼镜；即使戴着防护眼镜也绝不要直接看向激光束; 雷射房注意事项：确保所有人员熟悉激光系统，并知道如何在紧急情况下立即关闭激光系统; 光学安全：绝不允许反射物品（如珠宝、仪器或镜子）截取激光束；系统不使用时设为待机状态以防意外脉冲；无人看管时取出钥匙开关上的钥匙，或使用显示面板上受密码保护的屏幕锁定按钮，防止未经授权的使用
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. 22 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20173246844 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20173246844 valid until

  3. CN

    国械注进20173246844 change

    延续或变更注册获批（受理号 JQX2600935；2026年09月15日医疗器械批准证明文件送达信息）

  4. CN

    国械注进20173246844 change

    官网变更：见生产地址变化对比表。

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

3
  • 国械注进20173246844: 官网变更：见生产地址变化对比表。2026-10-16
  • 国械注进20173246844: 延续或变更注册获批（受理号 JQX2600935；2026年09月15日医疗器械批准证明文件送达信息）2026-09-11
  • 国械注进20173246844: certificate issued2017-10-17

Sources

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