Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033850524

FEI Number

3033850524

Entity Name

OFAN INTELLIGENT TECHNOLOGY (GUANGZHOU) CO. LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Floor 4rd Building F, Jintai Creation Park Jiahuo Helong No. 1 Rd. NO 6, Baiyun District, Guangzhou Guangdong 510000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OFAN Intelligent Technology (Guangzhou) Co. Ltd. (Owner Number: 10085922)

Owner / Operator Contact Address

Floor 4rd Building F, Jintai Creation Park Jiahuo Helong No. 1 Rd. NO 6, Baiyun District, Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242186

PMA Number

N/A

All Registered Proprietary Names

RF ems machine, ultrasound cavitation machine, shockwave therapy, cryolipolysis machine, microneedling RF Lower frequency machine, plasma machine, hydra facial machine, skin analyzer machine, High-Intensity Focused Ultrasound(HIFU) High frequency devices, LED devices, hair care devices, PEMF devices Neo sculptor, Model: OF-NEO001

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2025-01-12
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-10-30

Official Correspondent

Tequila Chan

US Agent Details

Ziyu Lu Email: FDA-Agent@h-kun.cn Phone: (347) 8283005

Related Public Records

Same Entity

OFAN Intelligent Technology (Guangzhou) Co. Ltd.

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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

Similar Registrations

Registration Number	Establishment Name	Location
3010337012	JEAN MARIE LORENZ S.R.L.	San Mango Piemonte Campania, IT
3012170108	JET TECH EUROPE S.R.L.	Milan Milano, IT
3005450640	EUNSUNG GLOBAL CORP.	Wonju-si Gangwon, KR
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3029972466	ASTERASYS CO., LTD.	Seongdong-gu Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033850524. Last updated year: 2026. Please use registration number 3033850524 when referencing this establishment in official correspondence.