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激光/强脉冲光治疗仪Icon Aesthetic System国械注进20163093102

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激光/强脉冲光治疗仪Icon Aesthetic System is a Energy-based device product (Class III device), registered by Cynosure, LLC. Linked registrations: China 国械注进20163093102. Data as of 2026-10-24.

  • Regulatory classEnergy-based device · Class III device
  • HolderCynosure, LLC
  • JurisdictionsCN · TW
  • Updated2026-10-24 · v1

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

Registration and basics

激光/强脉冲光治疗仪Icon Aesthetic System

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20163093102 (expired)
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
2021-04-14
Valid until
2026-04-13
Models and sizes
Icon
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)
Indications1540 手握把：1540 手握把用于软组织凝结，以及治疗黑斑、手术疤痕。; MaxG 手握把：MaxG 用于色素沉着病变的治疗、血管病变的治疗。; 2940 手握把：2940 手握把用于外科应用，包含软组织切割、消融、汽化、凝结；适应症包含：磨皮、表皮痣、微血管扩张、蜘蛛网状静脉、疣、角化、疤痕修复。; MaxY、MaxYs 手握把：MaxY、MaxYs 用于除毛（皮肤类型 I-VI）、色素沉着病变的治疗（皮肤类型 I-VI）。; MaxR、MaxRs 手握把：MaxR、MaxRs 用于除毛（皮肤类型 I-VI）。; 1064+ 手握把：1064+ 手握把用于皮肤类型 I-V 的除毛，治疗痣、刺青（黑色和/或蓝黑色纹身的强度显着降低）；血管病变的治疗；软组织凝结和止血。
Contraindications原文未报告Not reported
Composition不适用N/A
Storage运送/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不可将手握把对着空气发射；进行治疗起点测试时，请按照原厂操作手册中针对手握把治疗的部分进行操作。; 应对接受治疗者进行教育，并提供关于治疗性质及期望的信息。; 勿将手握把浸于任何溶液；将手握把浸湿可能对使用者与治疗对象造成危害及机器故障。; 本产品未使用时，确保未经授权的人员无法开启使用，将仪器的钥匙取下使仪器无法运作，并将仪器放在上锁的地方。; 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。; 眼睛不可直视手握把光发射端发出的光，否则会造成眼睛的伤害。; 如同其他光电设备，不可直视仪器输出的光；治疗过程中所有人员都须穿戴适当的防护眼镜，以防止可能对眼睛的伤害。; 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。
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20163093102 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20163093102 change

    官网变更：原注册证生产地址由5 Carlisle Road, Westford, Massachusetts 01886 USA 变更为：127 Hartwell St. West Boylston, MA USA 01583； 5 Carlisle RD, Westford, …

  3. CN

    国械注进20163093102 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20163093102 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20163093102 change

    延续或变更注册获批（受理号 JQX2401555；2026年03月12日医疗器械批准证明文件送达信息）

  6. CN

    国械注进20163093102 change

    官网变更：产品技术要求变更，详见变更对比表。

  7. CN

    国械注进20163093102 change

    产品技术要求变更，详见变更对比表。

  8. CN

    国械注进20163093102 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20163093102: 延续或变更注册获批（受理号 JQX2401555；2026年03月12日医疗器械批准证明文件送达信息）2026-03-11
  • 国械注进20163093102: 官网变更：产品技术要求变更，详见变更对比表。2026-03-11
  • 国械注进20163093102: 产品技术要求变更，详见变更对比表。2026-03-11
  • 国械注进20163093102: 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。2024-01-18
  • 国械注进20163093102: 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。2024-01-18

Sources

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