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

Ydun

Name: ydun
Brand: ydun

The FDA filing identifies Ellipse Ydun, model 9SYS7852, with the Frax 1550 handpiece. It describes Ydun as a console that drives the applicator, which emits 1550 nm laser light in a…

Registry build 21.09.26

The FDA filing identifies Ellipse Ydun, model 9SYS7852, with the Frax 1550 handpiece. It describes Ydun as a console that drives the applicator, which emits 1550 nm laser light in a fractionated pattern.

The filing states that the Ydun system is intended for dermatological procedures requiring soft tissue coagulation and for skin resurfacing. These statements concern the Ydun system with the associated Frax 1550 applicator.

System Components

The console contains a power unit, control electronics, a control and display panel, and software. The Frax applicator connects to the system.

92manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

2recalls on this 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 ydun
Listed by	Ellipse A/S, Denmark
FDA product code	GEX
Device type	Powered Laser Surgical Instrument
Device class	Class 2
Regulation	21 CFR 878.4810
510(k)	K180406
Record published	2021-03-16
Record revised	2023-02-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for ydun
Catalogue number	Size	Status
9SYS7852		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
K192951	2020-03-26
K180406	2018-03-15
K161162	2016-09-16
K150907	2015-07-07
K081408	2008-10-17
K072023	2007-09-12

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-05-05	Class II	Radiation Control for Health and Safety Act	Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.	US – 25	2016-07-29
2016-05-05	Class II	Radiation Control for Health and Safety Act	Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.	US – 14	2016-07-29

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.