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半导体激光治疗仪Medical electrical Diode Laser based device国械注进20143095299

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半导体激光治疗仪Medical electrical Diode Laser based device is a Energy-based device product (Class III device), registered by Alma Lasers Ltd. Linked registrations: China 国械注进20143095299. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderAlma Lasers Ltd
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

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

Registration and basics

半导体激光治疗仪Medical electrical Diode Laser based device

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20143095299
Registrant
以色列飞顿激光有限公司Alma Lasers Ltd
China agent
阿尔玛飞顿科技（成都）有限公司
First approval
Not obtained from an official source
This certificate issued
2023-08-01
Valid until
2029-08-26
Models and sizes
Soprano ICE
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除毛
Contraindications治疗前和治疗后3至4周内长期暴露于阳光或人工晒黑; 有凝血功能障碍病史; 癌症；特别是皮肤癌; 治疗区域活动性单纯疱疹感染; 糖尿病（胰岛素依赖型）; 可能被810nm光刺激的疾病; 怀孕（包括IVF）; 使用光敏感药物和草药，且810nm光照为禁忌; 使用抗凝剂; 有瘢痕疙瘩病史
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 reactionsSOPRANO XL：过度肿胀：治疗后立即出现，尤其在鼻部，可能持续长达7天。; SOPRANO XL：治疗部位的不适感包括刺激、刺痛、中度灼热感与疼痛，可能持续48小时。; SOPRANO XL：瘀斑：治疗区域可能出现紫癜或瘀斑，可能持续数小时至数天。; SOPRANO XL：治疗后数天到数周可能出现结痂、表皮区域及治疗周边发生色素沉着。; SOPRANO XL：色素改变：治疗区域可能出现色素改变。多数色素减退或色素沉着发生在皮肤类型IV至VI者，或治疗区域在治疗前后3周内暴露于阳光者；部分患者即使防晒仍出现色素沉着。此变色通常3至6个月消退，但罕见情况下（主要为色素减退）色素改变可能永久存在。; SOPRANO XL：严重或延长的发红及水肿，可能在治疗后持续2-24小时，甚至延迟数周。; SOPRANO XL：眼部损伤：反射或长时间未防护暴露于强光可造成眼部损伤；所有治疗期间必须佩戴与波长相适应的防护眼镜以预防眼损伤。; SOPRANO XL：疤痕：有形成疤痕的可能，例如增大的肥厚性疤痕或瘢痕疙瘩。为降低疤痕风险，需仔细遵循所有治疗前和治疗后指示。
Warnings如果治疗区域非常靠近眼睛（例如眼睑），使用角膜护罩保护眼睛。; 使用紧急按钮时可能产生危险电压。; 治疗期间治疗室内所有人员（患者和医务人员）必须佩戴Alma Lasers推荐的防护眼镜以保护眼睛。; 烧伤危险：Soprano^发射高强度光/激光辐射，肉眼不可见，可造成三度烧伤。; 二极管或NIR模块需使用不同的防护眼镜，必须选择正确类型。; 不适当操作本激光仪器容易产生各种伤害，请随时注意本手册各项安全防护指示；小心操作仍可能产生严重灼伤，不要治疗敏感及循环不良的区域，小孩与不合适的人操作极易产生危险。; 仅在紧急情况下使用紧急关闭旋钮。; 治疗前务必进行皮肤剂量反应测试，过量的治疗能量常造成不必要的副作用。
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. 35 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20143095299 change

    官网变更：注册人住所由:14 Halamish Street,Caesarea North Industrial Park,38900,Israel;注册人住所变更为:18 Haharash Street,Caesarea North Industrial Park 307989…

  2. CN

    国械注进20143095299 change

    注册人住所由:14 Halamish Street,Caesarea North Industrial Park,38900,Israel;注册人住所变更为:18 Haharash Street,Caesarea North Industrial Park 3079895 CAE…

  3. CN

    国械注进20143095299 change

    官网变更：本次变更内容如下：原注册证中生产地址由“14 Halamish Street, Caesarea North Industrial Park, 38900, Israel”变更为“18 Haharash Street, Caesarea North Industrial…

  4. CN

    国械注进20143095299 change

    本次变更内容如下：原注册证中生产地址由“14 Halamish Street, Caesarea North Industrial Park, 38900, Israel”变更为“18 Haharash Street, Caesarea North Industrial Park…

  5. CN

    国械注进20143095299 change

    官网变更：代理人名称由飞顿贸易（北京）有限公司；代理人住所由北京市朝阳区建华南路6号院1号楼6层702; 变更为：阿尔玛飞顿科技（成都）有限公司；变更为：四川省成都市武侯区人民南路四段46号附1号2栋18楼1801号附6号

  6. CN

    国械注进20143095299 change

    代理人名称由飞顿贸易（北京）有限公司；代理人住所由北京市朝阳区建华南路6号院1号楼6层702; 变更为：阿尔玛飞顿科技（成都）有限公司；变更为：四川省成都市武侯区人民南路四段46号附1号2栋18楼1801号附6号

  7. CN

    国械注进20143095299 this certificate issued

    Issue date of this certificate, not the first approval

  8. CN

    国械注进20143095299 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20143095299: certificate issued2023-08-01
  • 国械注进20143095299: 官网变更：代理人名称由飞顿贸易（北京）有限公司；代理人住所由北京市朝阳区建华南路6号院1号楼6层702; 变更为：阿尔玛飞顿科技（成都）有限公司；变更为：四川省…2023-07-13
  • 国械注进20143095299: 代理人名称由飞顿贸易（北京）有限公司；代理人住所由北京市朝阳区建华南路6号院1号楼6层702; 变更为：阿尔玛飞顿科技（成都）有限公司；变更为：四川省成都市武侯…2023-07-13
  • 国械注进20143095299: 官网变更：本次变更内容如下：原注册证中生产地址由“14 Halamish Street, Caesarea North Industrial Park, 389…2023-06-27
  • 国械注进20143095299: 本次变更内容如下：原注册证中生产地址由“14 Halamish Street, Caesarea North Industrial Park, 38900, I…2023-06-27

Sources

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