Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004505220

FEI Number

3004505220

Entity Name

SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

2F, Building 11, Lane 1175, Tongpu Road, Shanghai 200333, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD (Owner Number: 10044427)

Owner / Operator Contact Address

2F, Building.11, Lane 1175, Tongpu Road, Shanghai, CN-SH 200333, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161356

PMA Number

N/A

All Registered Proprietary Names

Picasso Sparkling medley cheveux Diode Laser System Matrix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-08-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-06-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-08-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-09-26
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-03-22
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2024-03-22
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2024-03-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-03-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-09-13

Official Correspondent

Feng Ye

US Agent Details

Raymond Steppling Business: Saratoga Aesthetics, LLC Email: ray.steppling@gmail.com Phone: (803) 7884979

Related Public Records

Same Entity

SHANGHAI WONDERFUL OPTO-ELECTRICS 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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

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3014384451	LAMEDITECH CO., LTD.	Seoul, KR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004505220. Last updated year: 2026. Please use registration number 3004505220 when referencing this establishment in official correspondence.