Data / Medical devices / South Korea / WEERO Co., Ltd.
WEERO Co., Ltd.: FDA-registered device maker in Suwon-si,Gyeonggi-do, South Korea, 6 510(k) clearances
WEERO Co., Ltd. is registered with the FDA (registration 3016087653) in Suwon-si,Gyeonggi-do, South Korea. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016087653
- Address
- A-205, Venture Valley II, 142-10, Saneop-ro 156 beon-gil, Gwonseon-gu, Suwon-si,Gyeonggi-do, South Korea, 16648
- Owner or operator
- WEERO Co., Ltd. (10085464)
- Roles
- Manufacturer
- First device listed
- June 21, 2022
- Registered through
- 2027
- Brand names listed
- Apollo Quattro, Apollo duet / APD-4000, EVE Ace of Face, EVE Synergy, EVE Titan, Wavefacial, eMVFit / MVF-10M
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Contact Cooling For Skin Lesion Pain Relief | QPZ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Iontophoresis, Other Uses | EGJ | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | 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 |
|---|---|---|---|---|---|---|
| June 8, 2026 | K253542 | Apollo Quattro (APQ-10M) | IPF | Substantially Equivalent | Weero Co., Ltd. | accessdata.fda.gov |
| March 13, 2026 | K253261 | Apollo Quattro (APQ-10M) | PBX | Substantially Equivalent | Weero Co., Ltd. | accessdata.fda.gov |
| June 4, 2025 | K241433 | EVE Synergy (EVE-20M) | IPF | Substantially Equivalent | Weero Co., Ltd. | accessdata.fda.gov |
| October 10, 2024 | K240992 | eMVFit (MVF-10M) | IPF | Substantially Equivalent | Weero Co., Ltd. | accessdata.fda.gov |
| October 9, 2024 | K240991 | eMVFit (MVF-10M) | PBX | Substantially Equivalent | Weero Co., Ltd. | accessdata.fda.gov |
| August 25, 2022 | K212253 | Apollo Duet (Model : APD-4000) | PBX | Substantially Equivalent | Weero Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Iontophoresis, Other Uses
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Stimulator, Muscle, Powered
- All makers of Pad, Heating, Powered
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Brush, Dermabrasion, Powered
Updated June 8, 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.