Powered Laser Surgical Instrument
Foot Switch (Foot switch assy : SPECTRA, GENIUS, ADVANTAGE, CLARITY, INFINI, eCO2 Plus, DENTA II etc.)
92manufacturers in China registered for this device type
57catalogue numbers in this listing
20510(k) clearances naming this product code
2recalls on this 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 | Lutronic Corporation, South Korea |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K091320 |
| Record published | 2016-09-09 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Handling environment temperature 20 to 30 °C; Handling environment humidity 30 to 70 % RH; Storage environment temperature 10 to 40 °C; Storage environment humidity 30 to 70 % RH |
| Packaging | Carton box, case of 10, box of 10, box of 12, carton case |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Manual | In distribution | |
| Metal Goggle (for patient) | In distribution | |
| SPECTRA Manual for USA | In distribution | |
| AC POWER CABLE | In distribution | |
| 1-7mm ZOOM HP (20%UP) | In distribution | |
| SD585 HP | In distribution | |
| Operator’s Manual | In distribution | |
| DENTA II arm | In distribution | |
| Pico Toning Collimated Handpiece (6-10mm) | In distribution | |
| SPⅢ ZOOM Handpiece Set | In distribution | |
| PICOPLUS ARM | In distribution | |
| ASSY HANDPIECE 10x10mm BAHR1060 | In distribution | |
| PETIT 90 Handpiece | In distribution | |
| ACTIONII ARM | In distribution | |
| LUT FILTER Goggle (for Operator) | In distribution | |
| ICD CARTRIDGE SET | In distribution | |
| Spectra Lotion for KSA | In distribution | |
| PICOPLUS Operator’s Manual (ENG, US) | In distribution | |
| LASEMD Operator’s Manual for USA | In distribution | |
| Foot Switch | In distribution | |
| SHININGPEEL Handpiece | In distribution | |
| Petit 360 Handpiece | In distribution | |
| Operator’s Goggle | In distribution | |
| CLARITY HANDPIECE+FIBER ASSY | In distribution | |
| Operator’s Manual | In distribution | |
| BLISTERED SQUARE SET | In distribution | |
| Hybrid Cooling Set | In distribution | |
| ARRAY Handpiece | In distribution | |
| Operator’s Goggle (532/1064nm) | In distribution | |
| 1-7 Zoom Handpiece | In distribution | |
| Foot Switch Assy | In distribution | |
| SD650 HP | In distribution | |
| SPⅢ Micro Handpiece Set | In distribution | |
| DENTA Zoom Handpiece Set | In distribution | |
| Operator’s Goggle | In distribution | |
| DENTA Handpiece Set | In distribution | |
| SPⅢ Handpiece Set | In distribution | |
| CLARITY ICD CAN ASSY 360g | In distribution | |
| CART ASSY | In distribution | |
| Zoom Handpiece (1-6mm) | In distribution | |
| ASSY HANDPIECE 10x10mm SAHR800 | In distribution | |
| Cooling gel | In distribution | |
| Spectra Lotion | In distribution | |
| Operator`s Manual | In distribution | |
| 3-8 ZOOM COLLIMATED HP (20%UP) | In distribution | |
| 5mm Dye Hand piece (585m) | In distribution | |
| Assy Foot switch | In distribution | |
| DENTA Micro Handpiece Set | In distribution | |
| eCO2 PLUS(USA) ARM | In distribution | |
| Spectra-standard ARM | In distribution | |
| BLISTERED COMB SET | In distribution | |
| ACTIONII Operator’s Manual for USA | In distribution | |
| BLISTERED ROLLER SET | In distribution | |
| Foot Switch | In distribution | |
| ASSY HANDPIECE 10x30mm BAHR800 | In distribution | |
| CLARITY ICD CAN ASSY 780g | In distribution | |
| TIP 9X9 | 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 |
| 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 |
|---|---|
| K213569 | 2022-02-04 |
| K203788 | 2021-03-26 |
| K183566 | 2019-06-14 |
| K173700 | 2018-06-19 |
| K171009 | 2017-06-23 |
| K163196 | 2017-05-24 |
| K141555 | 2014-11-06 |
| K130199 | 2013-11-22 |
| K113502 | 2012-04-05 |
| K113588 | 2012-02-22 |
| K103455 | 2011-04-28 |
| K101573 | 2010-09-23 |
| K091115 | 2009-10-30 |
| K091320 | 2009-08-19 |
| K082096 | 2008-10-08 |
| K080496 | 2008-07-07 |
| K080932 | 2008-06-09 |
| K080248 | 2008-04-23 |
| K073436 | 2007-12-28 |
| K070392 | 2007-07-13 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2026-08-06 | Not classified | Device Design | Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn. | 1065 |
| 2026-01-27 | Class II | Device Design | Reports of devices sparking/popping and potentially burning patients. | 1,525 units |
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.