Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016076077

FEI Number

3016076077

Entity Name

VIS (SHANGHAI) TECHNOLOGY CO., LTD.

City/State/Country

Jinshan District Shanghai, CN

Establishment Address

No. 58 Linsheng Road, Tinglin Town, Jinshan District Shanghai 201505, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

VIS (Shanghai) Technology, Co. Ltd. (Owner Number: 10066332)

Owner / Operator Contact Address

No. 58 Linsheng Town, Tinglin Town, Jinshan District, CN-SH 201505, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PEACH 2 duo PEACH 2 pro max PEACH 2 PEACH 2 go FAQ 201 FAQ 202 FAQ 202 Plus ISSA MINI SET ISSA COMPACT ISSA BABY ISSA PLAY ISSA HYBRID ISSA PRO SET ISSA ISSA 2 SENSITIVE SET ISSA KIDS SENSITIVE ISSA HYBRID BRUSH HEAD ISSA BRUSH HEAD ISSA MIKRO ISSA MINI 2 SENSITIVE ISSA 2 ISSA KIDS ISSA SENSITIVE ISSA 3 ISSA MINI ISSA MINI 2 ISSA MINI BRUSH HEAD ISSA MINI HYBRID ISSA MINI 3 ISSA 4 Smile ISSA 4 Baby ISSA 4 ISSA 4 Plus ISSA Baby Brush Head FAQ 102 FAQ 103 FAQ Dual LED Panel FAQ LED Panel ISSA Teeth whitening device Bear 2 body FAQ 302 Luna 4 plus FAQ 101

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	2023-11-20
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-11-20
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2024-04-23
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-04-23
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2020-04-01
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-07-18
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2024-07-18
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2024-07-18
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2026-02-24
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2026-02-24
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2026-04-27
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2024-05-16
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2024-12-15
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2024-08-22
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-08-22
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-11-20
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2023-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

Evan Feldstein Business: FOREO, INC. Email: evan.feldstein@foreo.com Phone: (702) 9062970

Related Public Records

Same Entity

VIS (Shanghai) 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016076077. Last updated year: 2026. Please use registration number 3016076077 when referencing this establishment in official correspondence.