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Q开关Nd:YAG激光治疗仪Q-Switched Nd:YAG Laser System国械注进20143095675

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Q开关Nd:YAG激光治疗仪Q-Switched Nd:YAG Laser System is a Energy-based device product (Class III device), registered by Cynosure, LLC. Linked registrations: China 国械注进20143095675. 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

Q开关Nd:YAG激光治疗仪Q-Switched Nd:YAG Laser System

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20143095675
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
2024-01-19
Valid until
2029-09-23
Models and sizes
RevLite SI
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原文未报告Not reported
Contraindications存在禁忌医学干预的一般医学状况。; 既往接受过肠道外金疗法（金硫代苹果酸钠）治疗。
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既往肠道外金疗法患者：接受过肠道外金疗法的患者若随后接受 RevLite™ 医疗激光系统治疗，可能发生局部金质沉着症；表现为日晒部位罕见的蓝灰色或蓝绿色皮肤变色，可持续长期。
Warnings始终从尽可能最低的能量水平开始治疗；如需更强的组织效应，以小增量提高能量水平，直至观察到所需的组织效应。; RevLite™ 医疗激光系统操作期间，所有在场人员必须佩戴 HOYA ConBio 随系统提供的激光安全护目镜。; 还必须根据激光治疗实施的部位，采取患者眼部保护措施。
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. 15 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20143095675 change

    官网变更：“注册人名称由: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20143095675 change

    “注册人名称由: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20143095675 this certificate issued

    Issue date of this certificate, not the first approval

  4. CN

    国械注进20143095675 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

  5. CN

    国械注进20143095675 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

  6. CN

    国械注进20143095675 change

    官网变更：产品技术要求变更内容详见《产品技术要求变更对比表》

  7. CN

    国械注进20143095675 change

    产品技术要求变更内容详见《产品技术要求变更对比表》

  8. CN

    国械注进20143095675 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20143095675: 官网变更：产品技术要求变更内容详见《产品技术要求变更对比表》2025-10-09
  • 国械注进20143095675: 产品技术要求变更内容详见《产品技术要求变更对比表》2025-10-09
  • 国械注进20143095675: 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2024-01-24
  • 国械注进20143095675: 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2024-01-24
  • 国械注进20143095675: certificate issued2024-01-19

Sources

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