LACEVO INC

FDA Device Registration & Listing · Greenville, DE, US · Registration 3035371451

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035371451
FEI Number
3035371451
Entity Name
LACEVO INC
City/State/Country
Greenville, DE, US
Establishment Address
3828 Kennett Pike Ste 212, Greenville, DE 19807, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Lacevo Inc (Owner Number: 10092600)
Owner / Operator Contact Address
3828 Kennett Pike, ste 212, Greenville, DE 19807, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K250829
PMA Number
N/A

All Registered Proprietary Names

LACEVO EMPOWER RED AND NEAR INFRARED LIGHT THERAPY BREAST CARE SET (Model: E1) Lacevo Wearable Breast Pump (Model S70)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2026-01-23
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-09-01

Official Correspondent

Sally Grice

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lacevo Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190465 Hygeia II Medical Group, Inc. Evolve Breast Pump 2019-10-18
K021739 Limerick, Inc. LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035371451. Last updated year: 2026. Please use registration number 3035371451 when referencing this establishment in official correspondence.
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