LightScalpel
5-Pack, Tip, 2.5mm Large Spot Size, Non-Sterile
92manufacturers in China registered for this device type
47catalogue numbers in this listing
6510(k) clearances naming this product 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.
| 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 | Lightscalpel Inc, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K141658 |
| Record published | 2016-09-24 |
| Record revised | 2026-05-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 40 to 70 % RH; Storage environment temperature 15 to 30 °C |
| Packaging | Box |
| Sizes | Lumen/inner diameter 0.25 to 3.2 mm; length 16.3 to 114 mm; length 1 to 1.75 m; length 13.5 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LSH-FST.4 | 0.4mm Spot Size | In distribution | |
| LSH-SCB | In distribution | ||
| LS9005-01 | Lumen/Inner Diameter 0.8 mm | 5 | In distribution |
| LSA-TR | In distribution | ||
| LSH-A110 | Angled | In distribution | |
| LS9001-01 | Length 19 mm | In distribution | |
| LSH-ST | Straight | In distribution | |
| LS-1005 | In distribution | ||
| LS9001-03 | Lumen/Inner Diameter 0.25 mm | In distribution | |
| LS-20111-01 | In distribution | ||
| LS-20113-01 | In distribution | ||
| LSF-175 | Length 1.75 m | In distribution | |
| LSA-FL | In distribution | ||
| LSH-ACB | In distribution | ||
| LS9005-05 | Thinwall | In distribution | |
| LS-20108-01 | In distribution | ||
| LS-20112-01 | In distribution | ||
| LSH-FST | 0.8mm Spot Size | In distribution | |
| LSH-LSTL | In distribution | ||
| LS9005-03 | Length 20 mm | 5 | In distribution |
| LSH-CB | In distribution | ||
| LSH-FA110 | 0.25mm Spot Size | In distribution | |
| LS9005-04 | Length 13.5 µm | 5 | In distribution |
| LS-20102-01 | In distribution | ||
| LS-20107-01 | In distribution | ||
| LS-2010 | In distribution | ||
| LS9001-05 | Thinwall | In distribution | |
| LS9001-04 | Lumen/Inner Diameter 0.8 mm | In distribution | |
| LS-4020 | In distribution | ||
| LS9028-01 | Length 114 mm | In distribution | |
| LS9005-06 | Length 16.3 mm | In distribution | |
| LSH-ADJ | In distribution | ||
| LS-20110-01 | In distribution | ||
| LS-20109-01 | In distribution | ||
| LS-F-1.5 | Length 1.5 m | In distribution | |
| LSH-LSLB | In distribution | ||
| LSH-FST.25 | 0.25mm Spot Size | In distribution | |
| LS9005-07 | Lumen/Inner Diameter 0.25 mm | 5 | In distribution |
| LSH-HCB | In distribution | ||
| LSH-XLS | In distribution | ||
| LS9001-02 | Lumen/Inner Diameter 0.4 mm | In distribution | |
| LS9005-02 | Length 20 mm | 5 | In distribution |
| H-S-T | Angled | In distribution | |
| H-A110 | Straight | In distribution | |
| LS9028-02 | Length 114 mm | In distribution | |
| LS-F-1.0 | Length 1.0 m | In distribution | |
| LS9034-01 | Length 114 mm | 5 | 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 |
|---|---|
| K213669 | 2023-02-15 |
| K173827 | 2018-09-14 |
| K141658 | 2014-10-22 |
| K132661 | 2014-01-02 |
| K123037 | 2012-11-29 |
| K121471 | 2012-07-10 |
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.