Endophotocoagulation Delivery Unit
This Endophotocoagulation Delivery Unit is used for endophotocoagulation. The delivery unit is comprised of an endophoto probe, a relay adapter, a protective filter unit, and a carrying…
This Endophotocoagulation Delivery Unit is used for endophotocoagulation. The delivery unit is comprised of an endophoto probe, a relay adapter, a protective filter unit, and a carrying case. The photocoagulation laser system can be easily formed by connecting the endophoto probe to the GREEN LASER PHOTOCOAGULATOR Model GYC-1000 main body and connecting the protective filter to the GYC-1000 main body and the surgical microscope. This photocoagulation laser system enables endophotocoagulation with the green laser (wavelength: 532 nm) while observing the affected area through the surgical microscope. This delivery unit is intended to be used with the protective filter unit attached to surgical microscopes. NIDEK provides following four types of delivery units according to the types of protective filters and the surgical microscopes*1. Before use, check the type of your surgical microscope and delivery unit.
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.
| 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
| 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 | 2019-09-07 |
| Record revised | 2026-04-10 (version 3) |
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 number | Size | Status |
|---|---|---|
| 11143-0000(9G4P) | In distribution | |
| 11143-0000(9M5P) | In distribution | |
| 17118-0000 | Withdrawn |
Same 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
| 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.
| 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.