Soprano Ice System 110v
Soprano ICE is a modular laser platform used in dermatologic and general surgical procedures. Its diode laser modules deliver energy for hair removal and permanent reduction in hair…
Soprano ICE is a modular laser platform used in dermatologic and general surgical procedures. Its diode laser modules deliver energy for hair removal and permanent reduction in hair regrowth. The platform accepts handpieces with different wavelengths and spot sizes, so the treatment function depends on the module connected.
The system includes a main console, a footswitch and treatment modules. Its 810 nm diode modules use contact cooling at the skin during treatment. The 1.2 square centimetre module provides hair removal modes and a laser blanch mode for benign vascular and pigmented lesions.
Module Scope
The 2 square centimetre 810 nm module provides hair removal modes. Both 810 nm modules are indicated for Fitzpatrick skin types I to VI, including tanned skin. Permanent reduction is assessed at six, nine and twelve months after treatment.
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 | Alma Lasers Ltd., Israel |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K140009 |
| Record published | 2016-09-24 |
| Record revised | 2023-02-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | 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 |
|---|---|
| K250071 | 2025-09-24 |
| K251230 | 2025-05-21 |
| K243044 | 2025-04-11 |
| K233024 | 2024-02-08 |
| K230308 | 2023-03-01 |
| K230371 | 2023-02-22 |
| K222064 | 2022-10-12 |
| K212073 | 2022-07-14 |
| K203441 | 2021-07-02 |
| K172193 | 2018-01-09 |
| K170850 | 2017-06-15 |
| K170626 | 2017-05-31 |
| K140009 | 2014-08-29 |
| K140005 | 2014-07-18 |
| K112031 | 2011-09-13 |
| K103501 | 2011-01-14 |
| K102716 | 2010-09-28 |
| K090571 | 2009-08-13 |
| K083848 | 2009-04-14 |
| K080463 | 2008-07-23 |
| K072182 | 2008-06-27 |
| K072564 | 2008-05-23 |
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.