What is FDA product code GEX?

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

General & Plastic Surgery › SurgicalPowered Laser Surgical Instrument

Waterlase MD Turbo Laser System

Name: Waterlase MD Turbo Laser System
Brand: Waterlase MD Turbo Laser System

An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a…

Registry build 21.09.26

An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.

92manufacturers in China registered for this device type

3catalogue numbers in this listing

33510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (28), Guangdong (21), Hebei (13). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEX
Manufacturer	City	Province	Registered as	Device types
Jabil Circuit (Shanghai) Ltd.	Shanghai	Shanghai	Contract manufacturer	31
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16
Beijing Winkonlaser Technology Limited	Beijing	Beijing	Contract manufacturer	14
Changsha Gomecy Electronics Co., Ltd.	Changsha	Hunan	Contract manufacturer	9
Gymmax Technology Shenzhen Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Guangzhou Niansheng Beauty Equipment Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	7
Beijing Syntech Laser Co., Ltd.	Beijing	Beijing	Contract manufacturer	5
VTech Communications Ltd	Dongguan	Guangdong	Contract manufacturer	5
Wuhan Dimed Laser Technology Co., Ltd.	Wuhan	Hubei	Contract manufacturer	3
Chengdu Vantron Technology Co., Ltd.	Chengdu	Sichuan	Contract manufacturer	1
Shanghai Shengguang Science & Technology Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	1
Guilin Woodpecker Medical Instrument Co., Ltd.	Guilin	Guangxi	Manufacturer	25

Showing 12 of 92. All 92 manufacturers in China registered for Powered Laser Surgical Instrument

Record

Regulatory record for Waterlase MD Turbo Laser System
Listed by	Biolase Technology, Inc., United States
FDA product code	GEX
Device type	Powered Laser Surgical Instrument
Device class	Class 2
Regulation	21 CFR 878.4810
510(k)	K090181
Record published	2016-09-15
Record revised	2023-06-12 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature 15 to 30 °C; Storage environment humidity 20 to 80 % RH

Catalogue Numbers

Catalogue numbers for Waterlase MD Turbo Laser System
Catalogue number	Size	Status
7200401 Refurbished		In distribution
7200401		In distribution
7200401 Refurbished		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Accu-Beam	Transamerican Technologies International	181
Powered Laser Surgical Instrument	Weinert Fiber Optics Inc.	117
Waterlase Laser Tips	Biolase Technology, Inc.	112
ProFlex™	Innovaquartz LLC	109
Dornier MedTech	Dornier Medtech America, Inc.	91
Powered Laser Surgical Instrument	Ophthalmed LLC	90
Optilite	Convergent Laser Technologies	87
Reusable Surgical Optical Fiber	Quanta System Spa	78
Single use Surgical Optical Fiber	Quanta System Spa	70
Powered Laser Surgical Instrument	Lutronic Corporation	57
Waterlase iPlus Dental Laser System	Biolase Technology, Inc.	53
Leoni™	Weinert Fiber Optics Inc.	49

Showing 12 of 2,654. All products under Powered Laser Surgical Instrument

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K210183	2022-04-21
K193486	2020-03-16
K192430	2019-12-04
K190319	2019-10-10
K172771	2017-11-29
K163128	2017-01-11
K161669	2016-07-28
K141975	2015-03-05
K140120	2014-10-10
K122368	2013-05-02
K130465	2013-04-11
K121327	2013-02-01
K121286	2012-09-28
K101658	2010-08-11
K093852	2010-03-12
K091746	2009-12-07
K083927	2009-10-01
K091922	2009-07-14
K090181	2009-02-11
K082938	2008-12-22
K083069	2008-11-13
K081589	2008-06-13
K071363	2008-02-12
K071734	2008-01-25
K061898	2007-01-26
K052354	2006-07-05
K031140	2004-07-07
K030523	2004-01-30
K030539	2003-10-10
K011041	2001-07-03
K003385	2001-01-25
K991994	1999-09-10
K950248	1995-02-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.