Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007113251

FEI Number

3007113251

Entity Name

PETER'S TECHNOLOGY (SUZHOU) CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 99 Jishi East Road, Wujiang District, Suzhou Jiangsu 215200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Peter's Technology (Suzhou) Co., Ltd. (Owner Number: 10026729)

Owner / Operator Contact Address

No. 99 Jishi East Road, Wujiang District, Suzhou, CN-JS 215200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Relign Arthroscopic System Aveta Max+ Disposable Resecting Device, 3.9mm Aveta Auto 5 Fr Disposable Resecting Device Aveta Wave+ Disposable Resecting Tip, 3.9mm Aveta Flex+ Disposable Resecting Device, 2.9mm Aveta Flex Disposable Resecting Tip, 2.9mm Aveta Smol Disposable Resecting Tip, 2.9mm Aveta Auto Disposable Resecting Device Aveta Flex Disposable Resecting Device, 2.9mm Aveta Opal Disposable Hysteroscope, 4.6mm Aveta Disposable Resecting Handset Aveta Max Disposable Resecting Device, 3.9mm Aveta Fluid Management Accessory Aveta Waste Management Accessory Aveta Roll Stand With Drape Pump Aveta Drape Pump Aveta Smol Disposable Resecting Device, 2.9mm Aveta Wave+ Disposable Resecting Device, 3.9mm TearCare SmartLids - accessory for TearCare System OMNI Surgical System OMNI Edge Surgical System Sion Surgical Instrument TearCare MGX SmartLids OMNI PLUS Surgical System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-01-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-01-20
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2020-11-11
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2020-11-11
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2022-01-26
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2023-10-18
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2023-10-18
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2022-07-03
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2025-04-27
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2023-01-03
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2023-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-05-24

Official Correspondent

Charlie Kuo

US Agent Details

Cary Kuo Email: caryjkuo@gmail.com Phone: (626) 2287665

Related Public Records

Same Entity

Peter's Technology (Suzhou) Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042158861	PT MEDTECH TH CO., LTD	PHRA NAKHON SI AYUTTHAYA, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007113251. Last updated year: 2026. Please use registration number 3007113251 when referencing this establishment in official correspondence.