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Q开关Nd:YAG激光治疗机 Q-Switching Nd:YAG Laser Device国械注进20173246592

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Q开关Nd:YAG激光治疗机 Q-Switching Nd:YAG Laser Device is a Energy-based device product (Class III device), registered by HLS Hypertech Laser Systems GmbH. Linked registrations: China 国械注进20173246592. Data as of 2026-10-23.

  • Regulatory classEnergy-based device · Class III device
  • HolderHLS Hypertech Laser Systems GmbH
  • JurisdictionsCN · TW
  • Updated2026-10-23 · v1

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

Registration and basics

Q开关Nd:YAG激光治疗机 Q-Switching Nd:YAG Laser Device

Product
Regulatory class
Class III device
Category
Energy-based device
China · NMPA device registration
国械注进20173246592 (expired)
Registrant
HLS Hypertech Laser Systems GmbH
China agent
北京海普泰克科技有限公司
First approval
Not obtained from an official source
This certificate issued
2017-08-30
Valid until
2022-08-29
Models and sizes
Biaxis QS
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)
Indications一般皮肤科及手术时针对软组织进行磨剥（消融）、切割、切除、汽化及凝结的治疗；色素病变治疗及刺青移除。
Contraindications对近红外波长的光过敏；服用增加光敏性的药物；服用抗凝血剂。; 18岁以下病人；治疗前一周内阳光照射；治疗区域有开放性伤口；已知有蟹足肿形成或创伤愈合功能低下。; 光诱发的癫痫；患者佩戴控制心脏的相关设备。; 发病中的传染性疾病；治疗区单纯疱疹感染；过去6周内化学或机械除毛。
Composition不适用N/A
Storage储存/运送温度为5°C至50°C。; 将本产品储存在空气干净且没有盐或酸等腐蚀性物质的地方；储存在干净的地方。
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副作用包括疼痛、红肿、肿胀、浮肿、红斑、紫癜、起水疱、湿疹，以及色素过少/色素沉着过度。
Warnings不使用本产品时，请将本产品钥匙放在治疗室外的位置。; 激光产生的烟雾是一种潜在生物危害，因为含有患者的皮肤颗粒，应以合适系统抽取所产生的烟雾。; 本产品为第4类激光，放射波长在电磁波谱的可见和不可见部分；激光辐射直接或间接接触眼睛会造成严重伤害，因此务必采取适当的预防措施。; 若在有易燃材料、溶液或气体的环境、或富氧环境中使用本产品，将存在引发火灾或爆炸的风险。; 请勿让未参与治疗且未受过激光操作训练的人员进入治疗室。; 本产品在高电压下运作，未接受相关训练者请勿打开保护盖。; 握把的外镜片绝不能接触除化学级纯丙酮或非变性酒精以外的清洁剂。; 治疗期间，房间内所有人员都必须佩戴合适的激光护目镜。
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. 23 of them are not yet reviewed by a person.

Registration timeline

  1. CN

    国械注进20173246592 this certificate issued

    Issue date of this certificate, not the first approval

  2. CN

    国械注进20173246592 change

    官网变更：“注册人名称：HLS Hypertech Laser Systems GmbH”变更为“注册人名称：HLS Hypertech Laser Systems GmbH 德国尖峰医疗激光技术有限公司”。

  3. CN

    国械注进20173246592 change

    “注册人名称：HLS Hypertech Laser Systems GmbH”变更为“注册人名称：HLS Hypertech Laser Systems GmbH 德国尖峰医疗激光技术有限公司”。

  4. CN

    国械注进20173246592 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

3
  • 国械注进20173246592: 官网变更：“注册人名称：HLS Hypertech Laser Systems GmbH”变更为“注册人名称：HLS Hypertech Laser Syste…2018-12-21
  • 国械注进20173246592: “注册人名称：HLS Hypertech Laser Systems GmbH”变更为“注册人名称：HLS Hypertech Laser Systems Gm…2018-12-21
  • 国械注进20173246592: certificate issued2017-08-30

Sources

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