Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037874486

FEI Number

3037874486

Entity Name

SOLAS MEDICAL LLC

City/State/Country

Dallas, TX, US

Establishment Address

3355 Blackburn St Unit 5402, Dallas, TX 75204, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Solas Medical LLC (Owner Number: 10093192)

Owner / Operator Contact Address

3355 Blackburn St Unit 5402, Dallas, TX 75204, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162659

PMA Number

N/A

All Registered Proprietary Names

Solas OmniPico Solas 10600 FX Solas IPL Solas IPL Pro Solas 10600 FX Solas QuadraDiode Solas 10600 FX Solas IPL Pro Solas IPL Pro Solas OmniPico Solas QuadraDiode Solas 10600 FX Solas IPL Solas 10600 FX Solas SonoSkin Solas OmniPico Solas 10600 FX Solas QuadraDiode

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	2025-09-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-31
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-05-17
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-09-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-02
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-09-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-05-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-27
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-05-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-05-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-09-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-09-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-09-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-04-13
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-02

Official Correspondent

Ciaran Smythe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solas Medical LLC

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
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

Similar Registrations

Registration Number	Establishment Name	Location
3014980477	ELEMENIC CO., LTD.	Seoul, KR
3009462521	Oncore Manufacturing, LLC dba NEOTech	Fremont, CA, US
3033905238	BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD.	Beijing, CN
3014384451	LAMEDITECH CO., LTD.	Seoul, KR
3010273372	WEIFANG KM ELECTRONICS CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037874486. Last updated year: 2026. Please use registration number 3037874486 when referencing this establishment in official correspondence.