Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023306694

FEI Number

3023306694

Entity Name

SHANGHAI SIGMA HIGH-TECH CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

The West Wing 1st FL, Building No.7&The East Wing 11th FL, Building No.8, No.388 Shuanglian Road, Xujing Town, Shanghai 201702, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai SIGMA High-tech Co., Ltd. (Owner Number: 10094696)

Owner / Operator Contact Address

The West Wing1st FL, Building No7&The East Wing 11th FL, Building No.8, No.388 Shuanglian Road, Xujing Town, Shanghai, CN-SH 201702, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242908

PMA Number

N/A

All Registered Proprietary Names

UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD);

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2025-12-17

Official Correspondent

Xing Guo

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Shanghai SIGMA High-tech 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
K800950	Tanit, Inc.	TANIT HOME SUNTANNING UNIT	1980-06-04
K230382	Daavlin Distributing Co.	3 Series NeoLux	2023-03-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023306694. Last updated year: 2026. Please use registration number 3023306694 when referencing this establishment in official correspondence.