Powered Laser Surgical Instrument
90 catalogue numbers from A21A000, listed by Ophthalmed LLC, United States, under Powered Laser Surgical Instrument. 92 manufacturers in China are registered for this product code.
92manufacturers in China registered for this device type
90catalogue numbers in this listing
1510(k) clearance
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 | Ophthalmed LLC, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K021696 |
| Record published | 2018-02-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Needle gauge 20 to 27 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A21A000 | Needle Gauge 20 G | In distribution |
| A874000 | Needle Gauge 23 G | In distribution |
| A375000 | Needle Gauge 25 G | In distribution |
| AA67000 | Needle Gauge 27 G | In distribution |
| AA65000 | Needle Gauge 27 G | In distribution |
| A373000 | Needle Gauge 25 G | In distribution |
| A259000 | Needle Gauge 20 G | In distribution |
| AA69000 | Needle Gauge 27 G | In distribution |
| A87A000 | Needle Gauge 23 G | In distribution |
| A218000 | Needle Gauge 20 G | In distribution |
| A822000 | Needle Gauge 23 G | In distribution |
| A879000 | Needle Gauge 23 G | In distribution |
| AA63000 | Needle Gauge 27 G | In distribution |
| AA28000 | Needle Gauge 27 G | In distribution |
| A377000 | Needle Gauge 25 G | In distribution |
| A212000 | Needle Gauge 20 G | In distribution |
| A322000 | Needle Gauge 25 G | In distribution |
| A258000 | Needle Gauge 20 G | In distribution |
| AA29000 | Needle Gauge 27 G | In distribution |
| AA24000 | Needle Gauge 27 G | In distribution |
| A823000 | Needle Gauge 23 G | In distribution |
| A363000 | Needle Gauge 25 G | In distribution |
| A872000 | Needle Gauge 23 G | In distribution |
| A23B000 | Needle Gauge 20 G | In distribution |
| A233000 | Needle Gauge 20 G | In distribution |
| AA27000 | Needle Gauge 27 G | In distribution |
| A254000 | Needle Gauge 20 G | In distribution |
| A257000 | Needle Gauge 20 G | In distribution |
| A87B000 | Needle Gauge 23 G | In distribution |
| AA6B000 | Needle Gauge 27 G | In distribution |
| AA2A000 | Needle Gauge 27 G | In distribution |
| A214000 | Needle Gauge 20 G | In distribution |
| A32B000 | Needle Gauge 25 G | In distribution |
| A329000 | Needle Gauge 25 G | In distribution |
| A215000 | Needle Gauge 20 G | In distribution |
| A878000 | Needle Gauge 23 G | In distribution |
| AA62000 | Needle Gauge 27 G | In distribution |
| AA23000 | Needle Gauge 27 G | In distribution |
| A37B000 | Needle Gauge 25 G | In distribution |
| A239000 | Needle Gauge 20 G | In distribution |
| A325000 | Needle Gauge 25 G | In distribution |
| A827000 | Needle Gauge 23 G | In distribution |
| A362000 | Needle Gauge 25 G | In distribution |
| A327000 | Needle Gauge 25 G | In distribution |
| A234000 | Needle Gauge 20 G | In distribution |
| A825000 | Needle Gauge 23 G | In distribution |
| A875000 | Needle Gauge 23 G | In distribution |
| A367000 | Needle Gauge 25 G | In distribution |
| A374000 | Needle Gauge 25 G | In distribution |
| A237000 | Needle Gauge 20 G | In distribution |
| A829000 | Needle Gauge 23 G | In distribution |
| A364000 | Needle Gauge 25 G | In distribution |
| A379000 | Needle Gauge 25 G | In distribution |
| AA25000 | Needle Gauge 27 G | In distribution |
| A328000 | Needle Gauge 25 G | In distribution |
| A368000 | Needle Gauge 25 G | In distribution |
| A365000 | Needle Gauge 25 G | In distribution |
| A324000 | Needle Gauge 25 G | In distribution |
| A372000 | Needle Gauge 25 G | In distribution |
| A252000 | Needle Gauge 20 G | In distribution |
| A873000 | Needle Gauge 23 G | In distribution |
| A235000 | Needle Gauge 20 G | In distribution |
| A238000 | Needle Gauge 20 G | In distribution |
| A36A000 | Needle Gauge 25 G | In distribution |
| A23A000 | Needle Gauge 20 G | In distribution |
| A255000 | Needle Gauge 20 G | In distribution |
| A232000 | Needle Gauge 20 G | In distribution |
| A82B000 | Needle Gauge 23 G | In distribution |
| AA64000 | Needle Gauge 27 G | In distribution |
| AA2B000 | Needle Gauge 27 G | In distribution |
| AA22000 | Needle Gauge 27 G | In distribution |
| A213000 | Needle Gauge 20 G | In distribution |
| A25A000 | Needle Gauge 20 G | In distribution |
| A25B000 | Needle Gauge 20 G | In distribution |
| AA6A000 | Needle Gauge 27 G | In distribution |
| A219000 | Needle Gauge 20 G | In distribution |
| A828000 | Needle Gauge 23 G | In distribution |
| A36B000 | Needle Gauge 25 G | In distribution |
| A253000 | Needle Gauge 20 G | In distribution |
| A21B000 | Needle Gauge 20 G | In distribution |
| A378000 | Needle Gauge 25 G | In distribution |
| A82A000 | Needle Gauge 23 G | In distribution |
| AA68000 | Needle Gauge 27 G | In distribution |
| A824000 | Needle Gauge 23 G | In distribution |
| A37A000 | Needle Gauge 25 G | In distribution |
| A217000 | Needle Gauge 20 G | In distribution |
| A877000 | Needle Gauge 23 G | In distribution |
| A32A000 | Needle Gauge 25 G | In distribution |
| A323000 | Needle Gauge 25 G | In distribution |
| A369000 | Needle Gauge 25 G | 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 |
| 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 |
| LightScalpel | Lightscalpel Inc | 47 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021696 | 2002-08-20 |
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.