Data / Medical devices / China / Shenzhen Breo Technology Co., Ltd
Shenzhen Breo Technology Co., Ltd: FDA-registered device maker in SHENZHEN Guangdong, China, 1 510(k) clearance
Shenzhen Breo Technology Co., Ltd is registered with the FDA (registration 3006206425) in SHENZHEN Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006206425
- Address
- 19/F, Hisense Southen Building, No. 1777 Chuangye Road Nanshan District, SHENZHEN Guangdong, China, 518056
- Owner or operator
- Shenzhen Breo Technology Co., Ltd (9093040)
- Roles
- Manufacturer
- First device listed
- September 29, 2006
- Registered through
- 2026
- Brand names listed
- Breo Eye Massager: iSee 4, iSee M, EM005, See 7, See 7C, See X3, Care MG 3, Care MG 5; See 7R; Comfy 5; See 5K, Breo Laser Hair Growth Comb, Breo Massage Gun: Sport-M0220, Sport-M310, Sport-M0500, Breo Neck Massager: Neck N5 mini, N6 mini, N7, Neck N1 Pro, N5 mini S3, Z6, N7Elite, Breo Scalp Trilogy Massager: Scalp 3, Scalp 3S, Breo Scalp3 Scalp Massaging Brush: Scalp 3, Foot Massager: FM D191, Relax 5, Relax 3, Foot 3, Foot 3 mini, Hand Massager: iPalm 520E, iPalm 520 Pro; WOWO S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 1, 2024 | K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | OAP | Substantially Equivalent | Shenzhen Breo Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 1, 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.