Cleared Traditional

Lacevo Wearable Breast Pump (Model S70)

K250829 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
Apr 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K250829 is an FDA 510(k) clearance for the Lacevo Wearable Breast Pump (Model S70), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Shenzhen TPH Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 17, 2025, 29 days after receiving the submission on March 19, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K250829 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2025
Decision Date April 17, 2025
Days to Decision 29 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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