Combination Attachable Delivery Unit (YC-1800)
This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while performing the observation with the slit…
This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 using the connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the green laser beam (wavelength: 532 nm (continuous wave)) and photodisruption with the Nd:YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laser beam with the laser select lever, and various kinds of safety devices are integrated into the system so that only the selected laser beam is emitted. The GYC2SZ-3A is the only combination delivery unit that can be connected both to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 and the NIDEK OPHTHALMIC YAG LASER SYSTEM YC-1800.
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 | 2017-02-03 |
| 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 |
|---|---|---|
| 17148-0000 | 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.