Data / Medical devices / United States / Lacevo Inc
Lacevo Inc: FDA-registered device maker in Greenville, DE, United States, 1 510(k) clearance
Lacevo Inc is registered with the FDA (registration 3035371451) in Greenville, DE, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035371451
- Address
- 3828 Kennett Pike Ste 212, Greenville, DE, United States, 19807
- Owner or operator
- Lacevo Inc (10092600)
- Roles
- Repackager or relabeler
- First device listed
- September 1, 2025
- Registered through
- 2026
- Brand names listed
- LACEVO EMPOWER RED AND NEAR INFRARED LIGHT THERAPY BREAST CARE SET (Model: E1), Lacevo Wearable Breast Pump (Model S70)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 17, 2025 | K250829 | Lacevo Wearable Breast Pump (Model S70) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 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.