BIOLASE MG LLC

FDA Device Registration & Listing · Corona, CA, US · Registration 3017125161

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
3017125161
FEI Number
3017125161
Entity Name
BIOLASE MG LLC
City/State/Country
Corona, CA, US
Establishment Address
4225 Prado Road, Suite 102, Corona, CA 92880, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MEGAGEN IMPLANT CO. LTD (Owner Number: 9067358)
Owner / Operator Contact Address
45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, KR-NOTA 42921, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K090181
PMA Number
N/A

All Registered Proprietary Names

Powered Laser Surgical Instrument Epic X/10/T-Series Epic Hygiene Epic Pro 980 Epic S- Series iLase EdgePro WL Express WL MDTurbo/Turbo HP

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 2025-01-02
DZI Drill, Bone, Powered Dental Class 2 872.4120 2025-01-02
MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation Dental Class 2 872.4120 2025-01-02
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
NVK Laser, Dental, Soft Tissue General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-01-02

Official Correspondent

Kwang Bum Park

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEGAGEN IMPLANT 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
3025029560 Megagen Implant Co., Ltd. (Seoul Branch) Seoul, KR
3030089804 MegaGen Implant Co., Ltd. (Secheon 2nd factory) Daegu, KR
3005554774 Megagen Implant Co., Ltd. Daegu, KR
3030089802 MegaGen Implant Co., Ltd. (Research Laboratories) Daegu, KR
2027755 BIOLASE MG LLC Foothill Ranch, CA, US

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 3017125161. Last updated year: 2026. Please use registration number 3017125161 when referencing this establishment in official correspondence.
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