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

BIO Delivery Unit (Keeler)

Name: BIO delivery unit (Keeler)
Brand: BIO delivery unit (Keeler)

This unit is connected to the NIDEK GREEN LASER DIODE PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area…

Registry build 21.09.26

This unit is connected to the NIDEK GREEN LASER DIODE PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. (HEINE OMEGA 180 TYPE). The comprised photocoagulation system makes it possible to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O..

92manufacturers in China registered for this device type

1catalogue number

23510(k) clearances naming this product code

3recalls 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 BIO delivery unit (Keeler)
Listed by	Nidek Incorporated, United States
FDA product code	GEX
Device type	Powered Laser Surgical Instrument
Device class	Class 2
Regulation	21 CFR 878.4810
Establishment	Specification developer, Manufacturer
Record published	2017-02-03
Record revised	2026-04-10 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Distribution end date	2024-12-10

Catalogue Numbers

Catalogue numbers for BIO delivery unit (Keeler)
Catalogue number	Size	Status
17120-0000		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
K131894	2013-10-31
K042785	2004-12-14
K032085	2003-10-03
K013864	2002-02-08
K990119	2000-07-27
K980475	1998-12-16
K982295	1998-08-06
K981447	1998-06-05
K980547	1998-05-13
K974732	1998-03-18
K980201	1998-03-16
K973828	1998-01-05
K970017	1997-03-18
K964353	1997-02-28
K913465	1991-10-21
K903639	1991-02-04
K904402	1990-12-07
K900925	1990-09-10
K900890	1990-09-10
K901481	1990-06-20
K900166	1990-03-27
K900165	1990-03-22
K894709	1989-10-04

Recalls

3 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
2015-03-25	Class II	Error in labeling	Accessories to the GYC-1000 laser were missing Laser Aperture labels.	22 units	2015-07-14
2015-03-25	Class II	Error in labeling	Accessories to the GYC-1000 laser were missing Laser Aperture labels.	W020 – 1 unit; 0Z20- 6 units	2015-07-14
2014-05-16	Class II	Radiation Control for Health and Safety Act	Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,	567 units	2014-10-16

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.