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Nd:YAG/KTP激光治疗机Aesthetic Dermatology Laser System国械注进20203091527

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Nd:YAG/KTP激光治疗机Aesthetic Dermatology Laser System is a Energy-based device product (Class III device), registered by CUTERA, INC.. Linked registrations: China 国械注进20203091527. Data as of 2026-10-28.

  • Regulatory classEnergy-based device · Class III device
  • HolderCUTERA, INC.
  • JurisdictionsCN · TW
  • Updated2026-10-28 · v1

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

Registration and basics

Nd:YAG/KTP激光治疗机Aesthetic Dermatology Laser System

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20203091527 (expired)
Registrant
酷特拉有限公司CUTERA, INC.
China agent
北京威尼汇力医疗器械有限公司
First approval
Not obtained from an official source
This certificate issued
2020-05-27
Valid until
2025-05-26
Models and sizes
Excel V
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)
IndicationsXeo SA：除毛；脸部血管丝治疗；老人斑、晒斑去除; Genesis Plus：老人斑、晒斑去除；血管治疗
Contraindications孕妇; 皮肤癌患者
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本器材之使用须符合《特定医疗技术检查检验医疗仪器施行或使用管理办法》之规定; 请依照操作手册使用
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. 15 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20203091527 change

    “注册人名称:CUTERA, INC.；代理人住所:北京市海淀区苏州街18号院长远天地大厦2号楼12A09室”变更为“注册人名称:CUTERA, INC. 酷特拉有限公司；代理人住所:北京市朝阳区朝阳门外大街20号1幢8层811B”。

  2. CN

    国械注进20203091527 change

    “代理人名称：捷通埃默高（北京）医药科技有限公司；代理人住所：北京市海淀区苏州街18号院-2楼12A08室”变更为“代理人名称：北京威尼汇力医疗器械有限公司；代理人住所：北京市朝阳区朝外大街22号1511室”。

  3. CN

    国械注进20203091527 this certificate issued

    Issue date of this certificate, not the first approval

  4. CN

    国械注进20203091527 change

    官网变更：代理人住所由北京市朝阳区朝外大街22号1511室 ;变更为：北京市朝阳区管庄周家井大院内世通大厦B座6层602号

  5. CN

    国械注进20203091527 change

    代理人住所由北京市朝阳区朝外大街22号1511室 ;变更为：北京市朝阳区管庄周家井大院内世通大厦B座6层602号

  6. CN

    国械注进20203091527 valid until

  7. CN

    国械注进20203091527 change

    延续或变更注册获批（受理号 JQX2500742；2026年10月20日医疗器械批准证明文件送达信息）

  8. CN

    国械注进20203091527 change

    官网变更：1. 产品名称由“Nd:YAG/KTP激光治疗机”变更为“Nd:YAG激光治疗机”。2. 产品技术要求变更对比表见附件。

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20203091527: 延续或变更注册获批（受理号 JQX2500742；2026年10月20日医疗器械批准证明文件送达信息）2026-10-16
  • 国械注进20203091527: 官网变更：1. 产品名称由“Nd:YAG/KTP激光治疗机”变更为“Nd:YAG激光治疗机”。2. 产品技术要求变更对比表见附件。2026-10-16
  • 国械注进20203091527: 官网变更：代理人住所由北京市朝阳区朝外大街22号1511室 ;变更为：北京市朝阳区管庄周家井大院内世通大厦B座6层602号2024-01-23
  • 国械注进20203091527: 代理人住所由北京市朝阳区朝外大街22号1511室 ;变更为：北京市朝阳区管庄周家井大院内世通大厦B座6层602号2024-01-23
  • 国械注进20203091527: certificate issued2020-05-27

Sources

3