Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013553501

FEI Number

3013553501

Entity Name

SLINPH TECHNOLOGIES CO., LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

Room201 and 202, Building B54, Jinke Yida Science & Technology City, No. 77 South Section of Dongliu Road, Changsha Economic and Technological Development Zone, Changsha Hunan 410100, CN

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Slinph Technologies Co., LTD (Owner Number: 10054743)

Owner / Operator Contact Address

Room201 and 202, Building B54, Jinke Yida Science & Technology City, No. 77 South Section of Dongliu Road, Changsha Economic and Technological Development Zone, Changsha, CN-HN 410100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190467

PMA Number

N/A

All Registered Proprietary Names

iHelmet Laser Comb (model: SC8 Dual, SC12, SC16Pro) IHelmet Hair Growth System iHelmet Hair Growth System, model: LTD 36Air iHelmet Hair Growth System, model: LTD 88Lite iHelmet Hair Growth System, model: LTD 160Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2021-12-20
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2017-04-20
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2020-01-11

Official Correspondent

KEVIN ZOU

US Agent Details

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

Related Public Records

Same Entity

Slinph Technologies Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013553501. Last updated year: 2026. Please use registration number 3013553501 when referencing this establishment in official correspondence.