Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009078366

FEI Number

3009078366

Entity Name

BEIJING GOLDENLASER DEVELOPMENT CO., LTD.

City/State/Country

Beijing, CN

Establishment Address

A2-53A, No. 65 South Third Ring West Road, Fengtai District, Beijing 100069, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Goldenlaser Development Co., Ltd. (Owner Number: 10087156)

Owner / Operator Contact Address

A2-53A, No. 65 South Third Ring West Road, Fengtai District, Beijing, CN-BJ 100069, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252427

PMA Number

N/A

All Registered Proprietary Names

Nd YAG Laser Therapy Systems:GL022,GL028,GL030,GL036,GL037, GL038,GL039 DIODE LASER MACHINE: GLD02, GLD03, GLD05, GLD06, GLD07, GLD08, GLD09, GLD11, GLD18, GLD19, GLD22, GLD23 COOLING DIODE LASER MACHINE: GLD12, GLD13, GLD15 CO2 FRACTIONAL LASER MACHINE: GL005, GL006, GL012, GL061, GL063 PICOSECOND LASER MACHINE: GL010, GL011, GL012, GL015, GL016, GL018, GL020, GL021 LED FACIAL BEAUTY MACHINE: GLQ01, GLQ02, GLQ03, GLQ05 LONG PULSE ND YAG LASER MACHINE: GL022A, GL028A, GL030A, GL036A ERBIUM LASER MACHINE: GLC01, GLC02, GLC03, GLC05 PICOSECOND LASER MACHINE: GL032, GL040 PLASMA LASER BEAUTY MACHINE: GL016, GL017, GL018 HIFU MACHINE: GLY01, GLY02, GLY03, GLY05, GLY06 IPL ELIGHT SHR HAIR REMOVAL MACHINE: GL003, GL007, GL008, GL012, GL013, GL015 CRYO SLIMMING MACHINE: GLV1, GLV2, GLV3, GLV5, GLV6, GLV8, GLV9, GLV10 DIODE LASER MACHINE: DLT05, DLT06, GLT07, GLT08 Q SWITCH ND YAG LASER MACHINE: GL015, GL016, GL017, GL018, GL019, GL023, GL025, GL026 Diode Laser Hair removal Machine: GLD01, GLD10, GLD16,GLD19

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	2026-04-13
NXF	Gas, Laser Generating	General, Plastic Surgery	Class 1	878.4810	2023-01-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-15

Official Correspondent

Xiaoxia Song

US Agent Details

Alex Gary Business: BTS US Inc Email: us@hibts.com Phone: (844) 9823583

Related Public Records

Same Entity

Beijing Goldenlaser Development 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 3009078366. Last updated year: 2026. Please use registration number 3009078366 when referencing this establishment in official correspondence.