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翠绿宝石激光治疗仪Candela Family of Multiple-Wavelength Laser System: GentleLASE Pro-U国械注进20193092300

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翠绿宝石激光治疗仪Candela Family of Multiple-Wavelength Laser System: GentleLASE Pro-U is a Energy-based device product (Class III device), registered by Candela Corporation. Linked registrations: China 国械注进20193092300. Data as of 2026-10-24.

  • Regulatory classEnergy-based device · Class III device
  • HolderCandela Corporation
  • JurisdictionsCN · TW
  • Updated2026-10-24 · v1

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

Registration and basics

翠绿宝石激光治疗仪Candela Family of Multiple-Wavelength Laser System: GentleLASE Pro-U

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20193092300
Registrant
凯德朗公司Candela Corporation
China agent
赛诺龙（北京）医疗科技有限公司
First approval
Not obtained from an official source
This certificate issued
2023-11-09
Valid until
2029-07-31
Models and sizes
GentleLASE Pro-U
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治疗色素沉着病变; 除毛; 治疗血管病变
Contraindications目标治疗范围内有开放性皮损时勿治疗；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预防; 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，请先将治疗区域与少量日晒区域比较; 勿治疗有光源性癫痫病史的患者; 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; 对于在755nm、1064nm或以上波长会增加光敏感性的药物，尽可能在治疗前3-5天内停用; 对755nm或1064nm激光具有光敏感病史; A酸治疗结束后6个月才可进行治疗; 日常服用抗凝药物、铁剂、草药（银杏、人参或大蒜）可能加重出现瘀青
Composition不适用N/A
Storage储存温度40℉~110℉（5℃~43℃）; 储存湿度20%~80%（非凝结）; 请勿将本系统暴露低于40℉（5℃），可能造成冰冻损害；如系统暴露低于40℉（5℃），使用前请与原厂联系
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）; 确认激光室内人员均熟悉操作本系统，并能在紧急状况发生时立即关闭系统; 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; 避免使用易燃的麻醉或氧化气体，如氧化氮和氧气；正常情况下激光产生的高温在富氧环境下可能点燃棉花或纱布等物质; 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; 操作本系统时只限受过训练的相关人员进入激光室; 使用本系统时所有人员应佩戴合适的护目镜
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. 32 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20193092300 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20193092300 change

    官网变更：产品技术要求变更见《产品技术要求变更对比表》。

  3. CN

    国械注进20193092300 change

    产品技术要求变更见《产品技术要求变更对比表》。

  4. CN

    国械注进20193092300 change

    官网变更：代理人住所由:北京市朝阳区建国路91号院9号楼28层2805-2808单元;代理人住所变更为:北京市朝阳区建国路79号31层31办公2T01内01、09B单元

  5. CN

    国械注进20193092300 change

    代理人住所由:北京市朝阳区建国路91号院9号楼28层2805-2808单元;代理人住所变更为:北京市朝阳区建国路79号31层31办公2T01内01、09B单元

  6. CN

    国械注进20193092300 change

    延续或变更注册获批（受理号 JQX2601040；2026年09月29日医疗器械批准证明文件送达信息）

  7. CN

    国械注进20193092300 change

    官网变更：产品技术要求变更：见产品技术要求变更对比表。

  8. CN

    国械注进20193092300 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20193092300: 延续或变更注册获批（受理号 JQX2601040；2026年09月29日医疗器械批准证明文件送达信息）2026-09-24
  • 国械注进20193092300: 官网变更：产品技术要求变更：见产品技术要求变更对比表。2026-09-24
  • 国械注进20193092300: 官网变更：代理人住所由:北京市朝阳区建国路91号院9号楼28层2805-2808单元;代理人住所变更为:北京市朝阳区建国路79号31层31办公2T01内01、0…2025-10-11
  • 国械注进20193092300: 代理人住所由:北京市朝阳区建国路91号院9号楼28层2805-2808单元;代理人住所变更为:北京市朝阳区建国路79号31层31办公2T01内01、09B单元2025-10-11
  • 国械注进20193092300: 产品技术要求变更见《产品技术要求变更对比表》。2025-01-27

Sources

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