Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007048256

FEI Number

3007048256

Entity Name

QUASAR ENGINEERING LTD.

City/State/Country

Kowloon, HK

Establishment Address

Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg, 19 Cheung Shun St, Cheung Sha Wan, Kowloon NONE, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Quasar Engineering Ltd. (Owner Number: 10025822)

Owner / Operator Contact Address

Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg, 19 Cheung Shun St, Cheung Sha Wan, Kowloon, HK-NOTA NONE, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230709

PMA Number

N/A

All Registered Proprietary Names

Microstream luer airway adapter Newa Skin Therapy System Auryon Atherectomy System OR Auryon Atherecomy Catheter Smart OmniLine Guardian Smart SureLine Guardian Microstream EtCO2 Sampling Smart CapnoLine GuardianTM Smart Capnoline Guardian Microstream O2/Co2 Oral Nasal Filterline Microstream EtCO2 Consumables ePlus skin treatment system Advance Pediatric Oral-Nasal Filter Line With O2 Tubing/Microstream Advance Adult Oral-Nasal Filter Line With O2 Tubing/Microstream Luer Adult Oral-Nasal Sampling Line Microstream Advance Neonatal-Infant Nasal Filter Line With O2 Tubing/Microstream eTwo Skin Treatment System Cuff Pressure Manometer Auryon Atherectomy System OR Auryon Atherecomy Catheter Microstream Luer Adult-Pediatric Intubated Sampling /line/Microstream Advance Adult-Pediatric Intubated Filter Line Profound Matrix Auryon Atherectomy System OR Auryon Atherecomy Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2011-12-07
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2020-07-01
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-03-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2011-11-16
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2008-05-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2015-07-09
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-06-23
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-13
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-09-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp. Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Quasar Engineering 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
3017844574	Quasar Medical (Thailand) Co., Ltd	Chonburi Chon Buri, TH
3014254831	Quasar Electronics Technology (Dongguan) Co., Ltd.	Dongguan Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007048256. Last updated year: 2026. Please use registration number 3007048256 when referencing this establishment in official correspondence.