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Q开关翠绿宝石激光治疗仪 Candela Family of Q-Switched Alexandrite Laser: Alex TriVantage国械注进20173247050

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Q开关翠绿宝石激光治疗仪 Candela Family of Q-Switched Alexandrite Laser: Alex TriVantage is a Energy-based device product (Class III device), registered by Candela Corporation. Linked registrations: China 国械注进20173247050. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderCandela Corporation
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

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

Registration and basics

Q开关翠绿宝石激光治疗仪 Candela Family of Q-Switched Alexandrite Laser: Alex TriVantage

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20173247050 (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
2017-11-22
Valid until
2022-11-21
Models and sizes
Alex TriVantage
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)
IndicationsGentleLase PRO：治疗色素病变; GentleLase PRO：治疗血管病变; GentleLase PRO：除毛
Contraindications请勿治疗开放性伤口和开放性感染的皮肤。; 怀孕。; 勿在最近日晒的皮肤上治疗，可能产生水泡反白或反黑；待晒后颜色褪去再治疗；如有疑问，先将治疗区域与少量日晒区域比较。; 对755nm激光具有光敏感病史。; 对于波长755nm内或以上会增加光敏感性的药物；尽可能在治疗前3-5天内停用该药物。; 勿治疗有光源性癫痫病史的患者。; 对波长755nm、1064nm内或以上会增加光敏感性的药物，尽可能在治疗前3-5天停用。; 目标治疗范围内有开放性皮损时请勿治疗；有频繁复发1型和2型单纯疱疹病史者，应按医师要求在治疗前进行预防。; 勿治疗有刺青的皮肤，包括装饰性、持久性彩妆和放射线植入的刺青图案。; 对755nm或1064nm激光有光敏感病史。; 若目标治疗范围内有开放性皮损，勿治疗；频繁复发1型和2型单纯疱疹病史者，应按医师要求在治疗前进行预防。; 日常服用抗凝药物、铁剂、草药（银杏、人参或大蒜）可能更容易出现瘀青。; 控制不良的疾病患者应由医师仔细评估其疾病恢复情况。; A酸治疗结束后6个月才可进行治疗。; 勿在最近日晒的皮肤上治疗，可能产生水泡、反白或反黑；待晒后颜色褪去再治疗；如有疑问先比较治疗区域与少量日晒区域。
Composition不适用N/A
Storage储存温度：40℉~110℉（5℃~43℃）。; 警告：请勿将系统暴露于低于温度40°F（5°C），可能造成冰冻损害；如系统暴露于低于温度40°F（5°C），使用前请与原厂联系。; 操作与储存湿度：20%~80%。; 操作与储存湿度：20%~80%（非凝结）。; 储存温度：40°F~110°F（5°C~43°C）。; 不可将系统暴露低于40℉（5℃），可能造成冰冻损害；如系统暴露低于40℉（5℃），使用前请联系原厂。
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禁止任何反光物（如首饰、器械或镜子）。; 除目标物或校正端口外，勿将激光对着任何物体。; 不使用本系统时请设定于待机状态以防止激光击发；不使用本系统时需移除钥匙或使用屏幕上的密码保护按键，以防止非授权使用。; 激光使用前，用于清洁或消毒的溶剂、黏合剂和易燃溶液需先挥发掉。; 使用本系统时所有人员应佩戴合适的护目镜。; 755nm/1064nm：使用本系统时所有人员应佩戴合适的护目镜；755nm使用光学密度≥5.8的护目镜，1064nm使用光学密度≥6.3的护目镜；使用非本系统的护目镜可能无法提供足够保护。; 除目标物或校正埠外，勿将激光对着任何物体。; 避免使用易燃的麻醉或氧化气体，如氧化氮和氧气；激光产生的高温在充满氧气的环境下可能点燃棉花、纱布等物质。; 不使用本系统时请设定于待机状态以防止激光击发。; 操作本系统时只限受过训练的相关人员进入激光房。; 不使用本系统时需将钥匙移除或使用屏幕上的密码保护按键，以防止非授权使用。; GentleMax Pro：维修GentleMax Pro时可能产生电或激光辐射危险，只有经原厂认可的工程师可以维修本产品。; 为避免触电危险，本器材必须接在有接地线保护的电源上。; 即使佩戴护目镜也不可直视激光光源。; 使用时需在激光房间各入口处明确设置警告标示。
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. 56 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20173247050 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20173247050 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

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  • 国械注进20173247050: certificate issued2017-11-22

Sources

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