Data / Medical devices / China / Beijing Sea Heart International Science And Technology Co.,ltd.
Beijing Sea Heart International Science And Technology Co.,ltd.: FDA-registered device maker in Beijing, China, 3 510(k) clearances
Beijing Sea Heart International Science And Technology Co.,ltd. is registered with the FDA (registration 3014388884) in Beijing, China. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014388884
- Address
- Room 4009, Building 4, Zhongke Jingwei Industrial Park No. 8 Yongchang Middle Road, Economic and Technological Development Zone, Beijing, China, 100176
- Owner or operator
- Beijing Sea Heart International Science And Technology Co.,L (10062040)
- Roles
- Exporter to the US
- First device listed
- December 12, 2019
- Registered through
- 2026
- Brand names listed
- CO2 Laser Therapy Systems, DND:YAG Laser Therapy Systems, Derma Roller : DR - 120, DR-192, DR-200, DR-400, DR-540, DR-600, DR-1080, DR-1200,, Derma Roller: Derma Roller 0.25mm, Microneedle Roller, Derma Roller: HR64,DS-12,DS-20,DS-32,DS-34,DS-80,DS-140,DS-140A, Derma Stamp: Derma Stamp 0.25mm, Dermabrasion Roller: Dermabrasion Stamp, Dermabrasion Roller, Diode Laser Hair Removal System: SH-VD500,SH-VD600,SH-VD700; SH-VD910,SH-VD920,SH-VD930; and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Exporter to the US | accessdata.fda.gov |
| Device, Pressure Applying | KNM | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Exporter to the US | accessdata.fda.gov |
| Static Electricity-Emitting Device, Cosmetic Use | NZF | N | 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 |
|---|---|---|---|---|---|---|
| September 17, 2024 | K242186 | Neo Sculptor (OF-NEO001) | NGX | Substantially Equivalent | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | accessdata.fda.gov |
| June 24, 2020 | K193477 | Nd: YAG Laser Therapy Systems | GEX | Substantially Equivalent | Beijing Kes Biology Technology Co., Ltd. | accessdata.fda.gov |
| July 6, 2017 | K162398 | CO2 Laser Therapy Systems | ONG | Substantially Equivalent | Beijing Sincoheren Science and Technology Development Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Static Electricity-Emitting Device, Cosmetic Use
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Therapeutic, Electric
- All makers of Device, Pressure Applying
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated September 17, 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.