Data / Medical devices / China / Rhein Laser Technologies Co., Ltd.
Rhein Laser Technologies Co., Ltd.: FDA-registered device maker in wuhan Hubei, China, 6 510(k) clearances
Rhein Laser Technologies Co., Ltd. is registered with the FDA (registration 3026038437) in wuhan Hubei, China. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026038437
- Address
- 6F, B2-A Building, No.999 High-Tech Avenue Future City, East Lake High-Tech Development Zone, wuhan Hubei, China, 430206
- Owner or operator
- Rhein Laser Technologies Co., Ltd. (10087178)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 22, 2023
- Registered through
- 2026
- Brand names listed
- 1300mW Handheld Laser, Artemis Diode Laser System(RL-S20S-TWC,RL-S20S-810B,RL-S20S-755), CELIORA (RLT-L4, RLT-L5, RLT-L6, RLT-E6), CELIORA L6, CELIORA L5, CELIORA L4, CO2-CRYO Cryo Therapy System, DL-1300mW Therapy System, Focused Shockwave 200, ML-MATEROBOT-30 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Cell-Freezing And Reagents | KSP | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 21, 2026 | K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | GEX | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. | accessdata.fda.gov |
| November 19, 2024 | K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | GEX | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. | accessdata.fda.gov |
| April 11, 2024 | K233757 | TitanPico Laser Workstation (PICO-450) | GEX | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. | accessdata.fda.gov |
| February 2, 2024 | K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) | GEX | Substantially Equivalent | Rhein Laser Technologies Co., Ltd. | accessdata.fda.gov |
| July 17, 2019 | K191068 | Powersculp laser lipolysis system | PKT | Substantially Equivalent | Wuhan Lotuxs Technology Co., Ltd. | accessdata.fda.gov |
| November 25, 2003 | K033015 | AXIOM BIOLASER LLLT SERIES-3 | NHN | Substantially Equivalent | Axiom Usa., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- All makers of Apparatus, Cell-Freezing And Reagents
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Therapeutic, Electric
Updated July 21, 2026. 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.