Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007120647

FEI Number

3007120647

Entity Name

SHANGHAI APOLO MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

Building 11, Lane 1566, Nanle Road, Songjiang District, Shanghai 201613, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Apolo Medical Technology Co.,Ltd. (Owner Number: 10026423)

Owner / Operator Contact Address

Building 11, Lane 1566, Nanle Road, Songjiang District, Shanghai, CN-SH 201613, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201109

PMA Number

N/A

All Registered Proprietary Names

980nm Diode Laser Therapy Device DuoVive Fiber Laser Treatment Systems SmoothPulse Portable SmoothPulse 3 Diode Laser Therapy Device Q-Switched Nd: YAG Laser System NanoVive SlimVive Diode Laser Body Sculpture System PulseVive IPL Treatment Systems Platform Treatment System PrimaVive Fiber Laser Treatment System Phototherapy System Infinity Pro PhotoVive PicoVive PicoSecond Nd: YAG Laser System NeoVive CO2 Laser Therapy System

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	2019-09-26
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2025-07-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-04-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-07-16
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2020-09-10
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2020-05-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-02-08
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2022-10-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-07-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-28
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-07-16

Official Correspondent

Felix Li

US Agent Details

Daniel Shen Business: Apolomed Inc. Email: daniel@apolomed.com Phone: (718) 6626288

Related Public Records

Same Entity

Shanghai Apolo Medical 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 3007120647. Last updated year: 2026. Please use registration number 3007120647 when referencing this establishment in official correspondence.