Data / Medical devices / China / Shenzhen Mareal Tech Co., Ltd
Shenzhen Mareal Tech Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Mareal Tech Co., Ltd is registered with the FDA (registration 3014327421) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014327421
- Address
- Room 211, Room 106-02, Building 28,Cuigang Industrial Zone 2,Huaide Community,Fuyong Street Bao'an District, Shenzhen Guangdong, China, 518103
- Owner or operator
- Shenzhen Mareal Tech Co., Ltd (10057169)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 2, 2018
- Registered through
- 2026
- Brand names listed
- (Home use)hair removal device, Model T21A, CACI IPL (FPL) Handset (Model: IPL(FPL) ), Home use hair removal device, Model T4, T5, T7, T8, Home use hair removal device, Model T4-01, T5-01, T8-01, IPL Hair Removal Device (Models: T31A, T32A), IPL Hair Removal Device/T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A, IPL Hair Removal Device/T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A, IPL Hair Removal Device/T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Contract manufacturer, Exporter to the US, 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 1, 2022 | K220248 | Home use hair removal device | OHT | Substantially Equivalent | Shenzhen Mareal Tech Co., Ltd. | accessdata.fda.gov |
| February 12, 2018 | K172883 | Home Use Hair Removal Device/T1, T2, T3 | OHT | Substantially Equivalent | Shenzhen Mareal Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 1, 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.