Rextar Pro— 510(k) K242185

Substantially Equivalent

Raypia Co., Ltd.

FDA 510(k) clearance K242185 for Rextar Pro, Substantially Equivalent on 2024-12-04. Applicant: Raypia Co., Ltd.. Device class: 2.

Clearance details

Applicant: Raypia Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2024-07-25
Decision date: 2024-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangseo-Gu, Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EHD

K260367 — Portable Dental X-ray System Model PDX nova2026-05-27
K253864 — NOMAD Pro 32026-03-20
K252110 — Dental X-RAY Unit (AJX200)2026-03-12
K254018 — Portable Dental X-ray Device (GT-1)2026-02-19
K252909 — Diagnostic X-Ray Equipment Model POCT222026-02-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.