Data / Medical devices / China / Beijing Jonte Laser Technology Co., Ltd
Beijing Jonte Laser Technology Co., Ltd: FDA-registered device maker in Beijing, China, 5 510(k) clearances
Beijing Jonte Laser Technology Co., Ltd is registered with the FDA (registration 3025379728) in Beijing, China. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025379728
- Address
- 9-802,Changyang Qihang International Phase III,Fangshan District,Beijing, Beijing, China, 102400
- Owner or operator
- Beijing Jonte Laser Technology Co., Ltd (10086366)
- Roles
- Exporter to the US
- First device listed
- November 3, 2022
- Registered through
- 2026
- Brand names listed
- 1060nm laser body slimming machine, Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13), Dermatological Carbon Dioxide Laser Systems, Dermatological Diode Laser Systems, Nd: YAG Laser Therapy System (QN-1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | K250722 | Nd: YAG Laser Therapy System (QN-1) | GEX | Substantially Equivalent | Hebei JT Medical Co., Ltd. | accessdata.fda.gov |
| May 13, 2024 | K240658 | 1060nm laser body slimming machine | PKT | Substantially Equivalent | Hebei JT Medical Co., Ltd. | accessdata.fda.gov |
| April 24, 2024 | K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) | NGX | Substantially Equivalent | Hebei JT Medical Co., Ltd. | accessdata.fda.gov |
| April 23, 2021 | K202257 | Dermatological Diode Laser Systems | GEX | Substantially Equivalent | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | accessdata.fda.gov |
| November 25, 2020 | K202250 | Dermatological Carbon Dioxide Laser Systems | GEX | Substantially Equivalent | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Powered Laser Surgical Instrument
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.