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Alovea Healthcare Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance

Alovea Healthcare Co., Ltd. is registered with the FDA (registration 3043105515) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3043105515
Address
Room 703, Building 1, No. 188 Fu Chun Jiang Rd, New District, Suzhou Jiangsu, China, 215163
Owner or operator
Alovea Healthcare Co., Ltd. (10094578)
Roles
Manufacturer
First device listed
December 9, 2025
Registered through
2026
Brand names listed
IPL Hair Removal Device/I6 S1, I6 D1, I6 M1

Devices it lists

DeviceProduct codeClassRoleSource
Light Based Over-The-Counter Hair RemovalOHT2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 14, 2025K252618IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)OHTSubstantially EquivalentAlovea Healthcare Co. , Ltd.accessdata.fda.gov

Compare with other makers

Updated November 14, 2025. 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.