Apollo Quattro (APQ-10M)— 510(k) K253261
Substantially EquivalentWeero Co., Ltd.
FDA 510(k) clearance K253261 for Apollo Quattro (APQ-10M), Substantially Equivalent on 2026-03-13. Applicant: Weero Co., Ltd.. Device class: 2.
Summary
Weero's Apollo Quattro (APQ-10M) is filed under PBX, radio frequency induced heat vacuum massagers. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.4400. It was a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
Weero filed from Suwon, South Korea. The decision came 165 calendar days after FDA received it (September 29, 2025 to March 13, 2026).
Clearance details
- Applicant
- Weero Co., Ltd.
- Product code
- Product code PBX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon, KR
Recent devices under product code PBX
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