Data / Medical devices / China / Wuhan Lotuxs Technology Co.,ltd.
Wuhan Lotuxs Technology Co.,ltd.: FDA-registered device maker in Wuhan Hubei, China, 6 510(k) clearances
Wuhan Lotuxs Technology Co.,ltd. is registered with the FDA (registration 3012294783) in Wuhan Hubei, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012294783
- Address
- 5F, E2 Building, No.999 Gaoxin Avenue, Future City, East Lake High-tech Development Zone, Wuhan,China, Wuhan Hubei, China, 430206
- Owner or operator
- Wuhan Lotuxs Technology Co.,Ltd. (10051850)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 8, 2019
- Registered through
- 2026
- Brand names listed
- Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064), LHR-S5-1064 DermRays Revive, LHR-V4S-810, LHR-V4-810, LHR-V8-810, LHR-V8S-810V Diode Laser Hair Removal, PowerCure/PowerCure PRO Therapy Device, PowerSculp laser lipolysis system, SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Complaint file establishment | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 30, 2024 | K231910 | DermRays Revive | GEX | Substantially Equivalent | Wuhan Lotuxs Technology Co., Ltd. | accessdata.fda.gov |
| November 28, 2023 | K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | GEX | Substantially Equivalent | Wuhan Lotuxs Technology Co., Ltd. | accessdata.fda.gov |
| July 30, 2023 | K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | GEX | Substantially Equivalent | Lotuxs Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| April 19, 2023 | K230090 | Diode Laser Hair Removal | OHT | Substantially Equivalent | Wuhan Lotuxs Technology 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 Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- All makers of Light Based Over-The-Counter Hair Removal
- 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 Light Based Over The Counter Wrinkle Reduction
Updated January 30, 2024. 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.