Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014386328

FEI Number

3014386328

Entity Name

ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD.

City/State/Country

zhangzhou Fujian, CN

Establishment Address

Room 401,No.7 Building,No. 228 Jiaosong Road,Jiaomei Town,Zhangzhou Taiwanese Investment Zone, zhangzhou Fujian 363100, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Zhangzhou Easepal Medical Science And Technology Co.,Ltd. (Owner Number: 10084572)

Owner / Operator Contact Address

Room 401,No.7 Building,No. 228 Jiaosong Road,Jiaomei Town,Zhangzhou Taiwanese Investment Zone, zhangzhou, CN-FJ 363100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CryoGlow LED Mask Shark Depuffi Shark FacialPro Glow IPL Salon Hair Reduction System Shark Depuffi Shark FacialPro Glow Redlight & Infrared LEDs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-12-16
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2024-12-16
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-05-21
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-03-27
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-08-25
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-03-17

Official Correspondent

Flower Huang

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Zhangzhou Easepal Medical Science And Technology 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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3015619973	JOICOM CORPORATION	Eastvale, CA, US
3011644607	Shenzhen Kaiyan Medical Equipment Co., Ltd	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014386328. Last updated year: 2026. Please use registration number 3014386328 when referencing this establishment in official correspondence.