Slit Lamp Delivery Unit (SL-1800)
This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. A slit lamp delivery unit…
This delivery unit is connected to the GYC-1000 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the GYC-1000 main body.
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 | 2016-06-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17421-0000 | In distribution |
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.