Data / Medical devices / China / Sanhe Laserconn Tech Co., Ltd.
Sanhe Laserconn Tech Co., Ltd.: FDA-registered device maker in Langfang Hebei, China, 1 510(k) clearance
Sanhe Laserconn Tech Co., Ltd. is registered with the FDA (registration 3012125201) in Langfang Hebei, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012125201
- Address
- X03-A Building, Baishijingu Industry Park, Yanjiao, Langfang Hebei, China, 065201
- Owner or operator
- Sanhe Laserconn Tech Co., Ltd. (10079395)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 15, 2021
- Registered through
- 2026
- Brand names listed
- Diode Laser Hair Removal System for Medical Use Milestone Smart-M, Diode Laser Hair Removal System for Medical Use Milestone Standard-A, Theralas Laser Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| November 7, 2022 | K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) | GEX | Substantially Equivalent | Sanhe Laserconn Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 7, 2022. 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.