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.

Pascal Synthesis, 577nm · Powered Laser Surgical Instrument → General & Plastic Surgery

Name: Pascal Synthesis, 577nm
Brand: Pascal Synthesis, 577nm

92manufacturers in China registered for this device type

1catalogue number

14510(k) clearances naming this product code

1recall

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 Pascal Synthesis, 577nm
Listed by	Iridex Corporation, United States
FDA product code	GEX
Device type	Powered Laser Surgical Instrument
Device class	Class 2
Regulation	21 CFR 878.4810
Establishment	Repacker / relabeller, Manufacturer
510(k)	K123542
Record published	2021-09-25

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -10 to 55 °C; Storage environment humidity 0 to 85 % RH

Catalogue Numbers

Catalogue numbers for Pascal Synthesis, 577nm
Catalogue number	Size	Status
PASCAL Synthesis 577- PA04		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
K181662	2018-09-05
K170718	2017-05-03
K162416	2016-09-29
K143154	2015-01-02
K121475	2012-11-28
K071687	2008-08-07
K062369	2006-11-08
K060905	2006-05-31
K050562	2005-04-14
K041930	2004-09-10
K022228	2002-10-08
K020849	2002-05-20
K992298	1999-12-09
K982031	1998-09-08

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Pascal Synthesis, 577nm
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Iridex Corporation	510(k) number	2016-07-15	Class II	Device Design	Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titra	205 units (21 in US, 184 OUS)	2019-01-29

Recalls

1 of these is 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
2018-02-27	Class II	Device Design	It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.	US – 58 OUS – 46	2023-09-22

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.

Pascal Synthesis, 577nm