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.

StoneLight 15 · Powered Laser Surgical Instrument → General & Plastic Surgery

Name: StoneLight 15
Brand: StoneLight 15

92manufacturers in China registered for this device type

1catalogue number

27510(k) clearances naming this product code

4recalls 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 StoneLight 15
Listed by	New Star Lasers, Inc., United States
FDA product code	GEX
Device type	Powered Laser Surgical Instrument
Device class	Class 2
Regulation	21 CFR 878.4810
Record published	2016-09-20
Record revised	2020-08-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2018-09-26

Catalogue Numbers

Catalogue numbers for StoneLight 15
Catalogue number	Size	Status
7300-0028		Withdrawn

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
K142286	2014-10-31
K132607	2014-03-21
K101783	2010-09-13
K092964	2009-12-11
K090410	2009-03-27
K081628	2008-06-20
K080163	2008-04-10
K072751	2008-01-02
K072424	2007-10-03
K062210	2006-09-25
K061618	2006-09-25
K051434	2005-08-09
K043046	2005-02-01
K041323	2004-11-17
K040131	2004-04-20
K031954	2003-08-21
K024259	2003-06-20
K031184	2003-05-21
K030453	2003-05-12
K023962	2002-12-24
K012982	2001-10-02
K002347	2000-08-17
K994273	2000-01-20
K973764	1997-12-31
K962791	1997-03-13
K952489	1996-01-22
K945156	1995-03-09

Recalls

4 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
2016-09-19	Class II	Labeling False and Misleading	FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.	17 systems	2016-12-13
2016-09-19	Class II	Labeling False and Misleading	FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.	5 systems	2016-12-13
2016-09-19	Class II	Labeling False and Misleading	FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.	44 systems CT3Plus; 47 systems CT3PZ	2016-12-13
2015-05-13	Class II	Software design (manufacturing process)	During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graph	52 units	2016-10-28

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.

StoneLight 15