Medcxy

Product dossierBuilt from registrations, label text and platform-curated data

射频治疗仪Radio Frequency System国械注进20163090059

Ask about this product

射频治疗仪Radio Frequency System is a Energy-based device product (Class III device), registered by Lutronic Corporation. Linked registrations: China 国械注进20163090059. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderLutronic Corporation
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

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

Registration and basics

射频治疗仪Radio Frequency System

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20163090059 (expired)
Registrant
（株）路创丽公司 Lutronic Corporation
China agent
路创丽医疗器械（上海）有限公司
First approval
Not obtained from an official source
This certificate issued
2020-08-31
Valid until
2025-08-30
Models and sizes
INFINI
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)
Indications650 nm（选配波长）：650 nm 波长：去除绿色刺青; 1064 nm：1064 nm 波长：除毛、除痣、治疗血管病变、治疗葡萄酒色斑; 585 nm（选配波长）：585 nm 波长：治疗色素病变、治疗血管病变; 532 nm：532 nm 波长：治疗色素病变、治疗血管病变
Contraindications有光敏感性、正在接受异维 A酸、类固醇或光敏化药物治疗的患者; 有愈合障碍的患者，例如糖尿病、结缔组织疾病、放射治疗或化疗引起的愈合障碍; 因强光引发癫痫的患者; 对局部麻醉剂、抗生素或其他药物过敏的患者; 精神官能症和/或酗酒或药物滥用史的患者; 有恶性肿瘤、癌症或癌前病变的患者; 有蟹足肿、疱疹感染、活动性湿疹史的患者; 怀孕或哺乳期的患者; 病变部位有疤痕、增生性疤痕、伤口、溃疡或严重炎症的患者; 有感染、治疗区域活动性感染、凝血功能障碍、光敏感性、对 Lidocaine / Prilocaine 过敏的患者
Composition不适用N/A
Storage相对湿度应保持在 0% 到 90% 之间，并将本产品安装在通风的地方，依温度保持适当湿度; 承接「最大海拔高度：标准商业运输高度」段落：温度：-5°C ~ 55°C；相对湿度：35°C 时为 90%，非冷凝；55°C 时为 32%，非冷凝; 大气压力范围为 80kPa~110kPa 内; 储存本产品的最佳温度范围为 10°C ~ 40°C 内；使用本产品的最佳温度范围为 20°C ~ 30°C
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危险（雷射光束）：接通系统电源后，切勿直视雷射孔或握把末端；即使穿戴雷射护目镜也可能导致严重眼部受伤或失明；切勿将雷射光束对准患者以外的任何物体; 眼睛保护：本系统产生肉眼不可见的近红外线以及可见光线；使用者和患者必须全程穿戴护目镜；手术中眼睛接触雷射光束可能导致严重损伤甚至失明; 握把操作前：每次操作前都必须清洁握把，内部透镜和握把头杂质应以 90% 以上浓度酒精去除，以维持效能; 火灾危险：在易燃物附近使用雷射时需特别小心，例如雷射光束打到麻醉剂、氮氧化物或氧气等气体，或酒精或棉花等易燃物，可能引起火灾; 电气灾害：切勿尝试拆解装置；非原厂授权及训练的人员不可拆解装置; 系统搬运：本产品重量约 84.7kg，处理不当可能损害系统内部和外部，可能影响功效; 眼睛保护：雷射光束可能被手术器械等光滑表面反射，所有与手术无关的工具在手术前应移至安全地方
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. 33 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20163090059 change

    官网变更：“注册人名称：Lutronic Corporation ”变更为“注册人名称：Lutronic Corporation（株）路创丽公司”。

  2. CN

    国械注进20163090059 change

    “注册人名称：Lutronic Corporation ”变更为“注册人名称：Lutronic Corporation（株）路创丽公司”。

  3. CN

    国械注进20163090059 change

    官网变更：生产地址由："Room 403-1, 2, 3, 4, 5, 404Ilsan Technotown 1141-1, Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, KOREA" 变更为：" 2F~4F, Pos…

  4. CN

    国械注进20163090059 change

    生产地址由："Room 403-1, 2, 3, 4, 5, 404Ilsan Technotown 1141-1, Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, KOREA" 变更为：" 2F~4F, Poskom t…

  5. CN

    国械注进20163090059 this certificate issued

    Issue date of this certificate, not the first approval

  6. CN

    国械注进20163090059 change

    官网变更：生产地址由“2F～4F, Poskom tower,227/Lutronic Center, 219, Sowon-ro, Deogyang-gu, Goyang-si, Gyeonggi-do, KOREA ”变更为“3F～4F, Poskom tower,227 /…

  7. CN

    国械注进20163090059 change

    生产地址由“2F～4F, Poskom tower,227/Lutronic Center, 219, Sowon-ro, Deogyang-gu, Goyang-si, Gyeonggi-do, KOREA ”变更为“3F～4F, Poskom tower,227 /Lutro…

  8. CN

    国械注进20163090059 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.

Cross findings · Price observations

Sign in to see findings and prices

Findings and prices stay out of indexable pages.

Sign in to view

Recent changes

5
  • 国械注进20163090059: 官网变更：生产地址由“2F～4F, Poskom tower,227/Lutronic Center, 219, Sowon-ro, Deogyang-gu, …2021-12-02
  • 国械注进20163090059: 生产地址由“2F～4F, Poskom tower,227/Lutronic Center, 219, Sowon-ro, Deogyang-gu, Goyan…2021-12-02
  • 国械注进20163090059: certificate issued2020-08-31
  • 国械注进20163090059: 官网变更：生产地址由："Room 403-1, 2, 3, 4, 5, 404Ilsan Technotown 1141-1, Baekseok-dong, I…2018-09-28
  • 国械注进20163090059: 生产地址由："Room 403-1, 2, 3, 4, 5, 404Ilsan Technotown 1141-1, Baekseok-dong, Ilsand…2018-09-28

Sources

8