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半导体激光治疗仪Medical electrical laser/NIR light system国械注进20163095120

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半导体激光治疗仪Medical electrical laser/NIR light system is a Energy-based device product (Class III device), registered by Alma Lasers Ltd. Linked registrations: China 国械注进20163095120. 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 laser/NIR light system

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20163095120
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
2021-10-25
Valid until
2027-06-14
Models and sizes
Soprano XLi
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)
IndicationsHR 手柄（650-950 nm）：除毛; SR 手柄（570-950 nm）：血管问题的治疗; VL/PL 手柄（540-950 nm）：血管及色素沉着问题的治疗; AC 手柄（420-950 nm）：浅表血管问题的治疗; Q开关 Nd:YAG 1064nm 手柄：纹身移除; Er:YAG 2940 nm 手柄：疤痕修复; Nd:YAG 1064nm 手柄：腿部静脉及血管问题的治疗
Contraindications怀孕; 蟹足肿体质; 3-4周内曾过度曝晒于天然及人工日晒者; 糖尿病控制不佳患者; 患有单纯疱疹; 使用光敏感药物且会对420-2940nm波长产生反应者; 罹患对420-2940nm波长产生反应的疾病患者; 使用口服A酸; 服用抗凝血剂; 癌症
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潜在治疗的副作用有不舒服、伤害正常皮肤触感、造成色素改变、产生斑痕、水肿、皮肤变脆弱及水泡紫斑; 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; 治疗后数天到数周可能会有结痂、表皮区域及治疗周边发生色斑沉着的情形; 严重或延长的发红及水肿，可能于治疗后持续2-24小时，甚至延迟数周
Warnings切勿触发脚开关，除非确认手握柄的治疗方向是安全地指向特定及想要治疗的目标; 医师及任何临床人员在使用本机器前务必阅读操作手册; 本机重60公斤，搬移时请小心安全，避免伤害；移动时请缓慢小心，并切勿推拉手握柄连接线的任何部分; 严禁任何非经受训人员使用本机; 治疗期间随时佩戴护目镜以免产生眼部伤害; 操作人员在机器处于可触发状态时，切勿任意离开; 切记维修仅可在关机及移除电源线时进行；若在开机或插电状态下进行维修步骤，将造成人员伤害及机器的损坏; 任何手柄的前光柄须随时保持洁净，并切记在每位患者治疗完后清洁光柄上的冷凝胶
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. 37 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20163095120 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20163095120 change

    官网变更：代理人名称由飞顿国际科技有限公司；代理人住所由成都市武侯区沙堰街40号1栋6层；代理人名称变更为：阿尔玛飞顿科技（成都）有限公司；代理人住所变更为：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

  3. CN

    国械注进20163095120 change

    代理人名称由飞顿国际科技有限公司；代理人住所由成都市武侯区沙堰街40号1栋6层；代理人名称变更为：阿尔玛飞顿科技（成都）有限公司；代理人住所变更为：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

  4. CN

    国械注进20163095120 change

    官网变更：注册人住所由14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,Israel;变更为：18 Haharash Street,Caesarea North Industrial Park …

  5. CN

    国械注进20163095120 change

    注册人住所由14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,Israel;变更为：18 Haharash Street,Caesarea North Industrial Park 30798…

  6. CN

    国械注进20163095120 change

    官网变更：进口生产地址由“14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,Israel”变更为“18 HaharashStreet,Caesarea North IndustrialPark3…

  7. CN

    国械注进20163095120 change

    进口生产地址由“14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,Israel”变更为“18 HaharashStreet,Caesarea North IndustrialPark307989…

  8. CN

    国械注进20163095120 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20163095120: 官网变更：进口生产地址由“14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900…2023-11-28
  • 国械注进20163095120: 进口生产地址由“14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,Isra…2023-11-28
  • 国械注进20163095120: 官网变更：注册人住所由14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,I…2023-10-26
  • 国械注进20163095120: 注册人住所由14 Halamish Street,PO BOX 3021,Caesarea North Industrial Park,38900,Israel…2023-10-26
  • 国械注进20163095120: 代理人名称由飞顿国际科技有限公司；代理人住所由成都市武侯区沙堰街40号1栋6层；代理人名称变更为：阿尔玛飞顿科技（成都）有限公司；代理人住所变更为：四川省成都市…2023-06-26

Sources

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