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翠绿宝石激光治疗仪Cynosure Accolade Laser国械注进20173096176

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翠绿宝石激光治疗仪Cynosure Accolade Laser is a Energy-based device product (Class III device), registered by Cynosure, LLC. Linked registrations: China 国械注进20173096176. 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

翠绿宝石激光治疗仪Cynosure Accolade Laser

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20173096176
Registrant
美国赛诺秀公司Cynosure, LLC
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
2024-04-17
Valid until
2031-08-02
Models and sizes
Accolade
Checked against official page
2026-10-23

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刺青：淡化黑色、蓝色、红色及绿色刺青。; 表皮及真皮：淡化表皮及真皮色素沉着病变。
Contraindications有皮肤癌个人史或家族史者禁用。; 对750nm至760nm波长区域光线产生敏感反应者禁用。; 孕妇禁用。
Composition不适用N/A
Storage原文未报告Not reported
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使用过高能量可能导致长期性色素过少症。; 使用过高能量可能导致疤痕。; 使用过高能量可能导致长期性色素沉着症。
Warnings确定适合后，医生应告知患者以下事项：达到预期效果所需的预计治疗次数；激光治疗可能产生的副作用；治疗后治疗区域的外观：治疗后立即出现白灰色变色，随后出现红斑或紫癜，并可能有结痂；病变或刺青逐渐清除。; 如果脚控开关或手持件开关发生故障并在激光发射时意外保持开启，迅速将手持件对准湿海绵以吸收激光能量。立即按下紧急激光停止按钮。; 插入、过度弯曲或未充分紧固光纤时存在潜在危险。应始终遵循本手册中的建议，避免损坏光纤、传输系统和/或可能对患者或操作者造成伤害。; 未保持校准口窗口清洁可能导致能量不正确，从而导致患者受伤。; 始终佩戴激光系统随附的防护眼镜。未佩戴适当的防护眼镜可能导致严重眼伤害。
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. 21 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20173096176 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:美国赛诺秀公司 Cynosure, LLC;”。

  2. CN

    国械注进20173096176 change

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

  3. CN

    国械注进20173096176 change

    官网变更：代理人住所由江苏省苏州市阊胥路251号远东大厦五楼;变更为：江苏省苏州市阊胥路575号203、204-1室

  4. CN

    国械注进20173096176 change

    代理人住所由江苏省苏州市阊胥路251号远东大厦五楼;变更为：江苏省苏州市阊胥路575号203、204-1室

  5. CN

    国械注进20173096176 this certificate issued

    Issue date of this certificate, not the first approval

  6. CN

    国械注进20173096176 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20173096176: certificate issued2024-04-17
  • 国械注进20173096176: 官网变更：代理人住所由江苏省苏州市阊胥路251号远东大厦五楼;变更为：江苏省苏州市阊胥路575号203、204-1室2024-01-19
  • 国械注进20173096176: 代理人住所由江苏省苏州市阊胥路251号远东大厦五楼;变更为：江苏省苏州市阊胥路575号203、204-1室2024-01-19
  • 国械注进20173096176: 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:美国赛诺秀公司 Cynosure, LLC;”。2019-08-15
  • 国械注进20173096176: “注册人名称:美国赛诺秀公司 Cynosure, Inc.;”变更为“注册人名称:美国赛诺秀公司 Cynosure, LLC;”。2019-08-15

Sources

7