TattooStar Effect Combo
TattooStar Effect Combo combines two laser sources for dermatologic procedures. Its stated uses include tattoo and selected lesion removal, skin resurfacing and soft tissue incision,…
TattooStar Effect Combo combines two laser sources for dermatologic procedures. Its stated uses include tattoo and selected lesion removal, skin resurfacing and soft tissue incision, excision, ablation or vaporization. The system can deliver different wavelengths according to the selected laser and handpiece.
The Nd:YAG laser emits at 1064 and 532 nanometres, with an optional dye handpiece converting output to 585 nanometres. The ruby laser emits at 694 nanometres. Both use Q switched pulses, and the Nd:YAG source also has an optional free running mode.
Listed Item
Dermatological laser with the wavelengths 1064 nm, 532 nm, 585 nm and 694 nm. Intended for the removal of tattoos, pigmented lesions, vascular lesions and skin resurfacing.
Beam Delivery
An articulated mirror arm carries light to the treatment handpiece. The ruby module’s listed applications include black, blue and green tattoos, while the Nd:YAG module has separate wavelength specific treatment settings.
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 | Asclepion Laser Technologies GmbH, Germany |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K131757 |
| Record published | 2016-11-14 |
| Record revised | 2021-08-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1680 | 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 |
|---|---|
| K261094 | 2026-04-29 |
| K253100 | 2025-10-23 |
| K241600 | 2024-07-03 |
| K240816 | 2024-04-23 |
| K231876 | 2024-02-22 |
| K213889 | 2022-04-22 |
| K210634 | 2022-04-13 |
| K192483 | 2020-03-13 |
| K161257 | 2017-03-31 |
| K152153 | 2015-12-11 |
| K150140 | 2015-06-05 |
| K143519 | 2015-03-10 |
| K133891 | 2015-01-30 |
| K131987 | 2014-10-15 |
| K131757 | 2014-07-17 |
| K133297 | 2014-06-10 |
| K113489 | 2012-07-27 |
| K112669 | 2012-05-11 |
| K111851 | 2011-07-08 |
| K081541 | 2009-02-23 |
| K071451 | 2007-08-01 |
| K060787 | 2006-09-27 |
| K060457 | 2006-03-20 |
| K060455 | 2006-03-20 |
| K060459 | 2006-03-20 |
| K050900 | 2005-05-16 |
| K042968 | 2004-11-24 |
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.