Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017222105

FEI Number

3017222105

Entity Name

LEADER LIGHT LIMITED

City/State/Country

HONG KONG, CN

Establishment Address

RM 504, PENINSULA CENTRE, 67 MODY ROAD, TSIM SHA TSUI, HONG KONG 00000, CN

Establishment Type(s)

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

Owner / Operator

Leader Light Ltd. (Owner Number: 10086360)

Owner / Operator Contact Address

RM 504, PENINSULA CENTRE, 67 MODY ROAD, TSIM SHA TSUI, HONG KONG, CN-HK 00000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Massager heating pad Heating Pad Neck wrist shoulder warmer patch Warm scarf wraps Cold compress eye patch Knee & elbow warmer belt Warm foot mask Joint heat patch Far-infrared heating pad Visible warm eye mask Multi-functional elastic gel heat patch Hydrogel warm patch Hydrogel patch Warm mask Hydrogel warm eye mask Cooling gel patch Warm facial mask Heat Pad Warm belt Warm eye mask Heat head mask Breast warmer patch Cooling gel sheet Warmer insole Mini warmer pad Neck & shoulder warmer Body warmer pad 3D warm eye mask Warm foot patch Gel heat patch Heat hair mask Elastic warm shoulder patch Menstrual warmer patch Elastic warm patch Waist heat belt Medical cold compress Hot patch Self-adhesive warm eye mask Hand warmer Cooling patch Hydrogel warm facial mask Heating cap Toe warmer Warm shoulder wraps Knee & elbow warmer patch Heat reducing plaster Warm gloves Gel face mask Warm hand mask Hydrogel eye patch Warm uterus pad massager

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRK	Evaporator	Clinical Chemistry	Class 1	862.2050	2023-11-17
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2024-10-10
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-10-10
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-11-02

Official Correspondent

Shelley Yu

US Agent Details

Aokai Tang Business: AOKT STUDIO LLC Email: aokt-service@outlook.com Phone: (757) 2240177

Related Public Records

Same Entity

Leader Light 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3027645317	INFITEK CO., LTD.	Shanghai, CN
3043088937	SCITEK GLOBAL CO.,LTD	Jinan Shandong, CN
3014153468	JIANGMEN HONETIAN TECHNOLOGY CO., LTD	Jiangmen Guangdong, CN
1000190272	LASKO PRODUCTS LLC	West Chester, PA, US
3022528821	J SUMMIT CO., LTD.	Chomthong Krung Thep Maha Nakhon, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017222105. Last updated year: 2026. Please use registration number 3017222105 when referencing this establishment in official correspondence.