GIGAALASER COMPANY LTD.

FDA Device Registration & Listing · Wuhan Hubei, CN · Registration 3017181358

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017181358
FEI Number
3017181358
Entity Name
GIGAALASER COMPANY LTD.
City/State/Country
Wuhan Hubei, CN
Establishment Address
B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road, Wuhan 430206, China, Wuhan Hubei 430206, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gigaalaser company ltd. (Owner Number: 10085437)
Owner / Operator Contact Address
B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road, Wuhan, CN-HB 430206, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242755
PMA Number
N/A

All Registered Proprietary Names

Medical Diode Laser Systems Medical diode laser systems Medical diode laser systems Medical diode laser systems THEIA Lipo Dua Medical diode laser systems VELASII-6H Medical diode laser systems VELAS Pro-30B15D Medical diode laser systems GBOX-6H Medical diode laser systems VELASII-15D Medical diode laser systems GBOX-10D, 12D, 15D Medical Diode Laser Systems

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EEG Heat Source For Bleaching Teeth Dental Class 1 872.6475 2024-04-02
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2024-04-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-04-02
NVK Laser, Dental, Soft Tissue General, Plastic Surgery Class 2 878.4810 2024-04-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-06-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-06-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-04-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-04-07
PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis General, Plastic Surgery Class 2 878.4810 2025-08-11
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2025-08-11

Official Correspondent

Rui Jia

US Agent Details

Alexander Braun Henderson Business: dba BraunSolutions Regulatory Group Email: BraunSolutions@live.com Phone: (720) 5894939

Related Public Records

Same Entity

Gigaalaser company 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, PA***SLT Fiber Delivery System***Sterile***Non-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 3017181358. Last updated year: 2026. Please use registration number 3017181358 when referencing this establishment in official correspondence.
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