Suprema 4v
Suprema 4V is a medical laser system used by dermatologists for specified skin treatments and hair removal. This model combines pulsed Nd:YAG sources at 1064 and 532 nm with an Alexandrite…
Suprema 4V is a medical laser system used by dermatologists for specified skin treatments and hair removal. This model combines pulsed Nd:YAG sources at 1064 and 532 nm with an Alexandrite source at 755 nm. Laser energy is delivered through optical fibres to compatible treatment handpieces.
A graphical display controls the system, while a footswitch or handpiece finger switch activates emission. The laser handpiece is used with a Skin Cooler or Skin Cryo housing, providing the required treatment arrangement. Depending on configuration, cooling comes from an integrated system or a compatible external cooler.
Listed Item
Aesthetic/dermatological laser device with Nd:YAG 1064 and 532 nm and Alex 755 nm Pulsed laser sources.
Clinical Scope
Its wavelength specific indications include treatment of selected benign vascular and pigmented skin lesions. The 1064 nm mode also has hair reduction indications. These uses take place in professional healthcare environments.
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 | Quanta System Spa, Italy |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K223404 |
| Record published | 2023-02-13 |
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 |
|---|---|---|
| PCMS00504 | 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 |
|---|---|
| K240983 | 2025-06-06 |
| K243588 | 2025-02-19 |
| K241092 | 2024-10-10 |
| K242251 | 2024-09-03 |
| K232236 | 2023-10-20 |
| K223404 | 2023-01-20 |
| K220426 | 2022-03-16 |
| K211228 | 2022-02-02 |
| K210142 | 2021-03-11 |
| K202503 | 2020-11-18 |
| K202041 | 2020-10-15 |
| K201455 | 2020-06-30 |
| K200234 | 2020-02-25 |
| K192600 | 2020-02-21 |
| K192990 | 2019-12-20 |
| K191842 | 2019-09-17 |
| K192160 | 2019-09-06 |
| K182669 | 2018-10-17 |
| K181632 | 2018-09-17 |
| K180922 | 2018-05-08 |
| K180426 | 2018-03-16 |
| K180423 | 2018-03-15 |
| K180158 | 2018-02-14 |
| K173002 | 2017-12-13 |
| K172376 | 2017-10-19 |
| K172198 | 2017-10-17 |
| K172025 | 2017-07-31 |
| K171945 | 2017-07-28 |
| K171711 | 2017-07-07 |
| K170331 | 2017-03-03 |
| K163222 | 2016-12-05 |
| K163009 | 2016-12-01 |
| K160368 | 2016-04-05 |
| K160513 | 2016-03-18 |
| K152714 | 2015-12-21 |
| K152012 | 2015-12-08 |
| K151629 | 2015-10-27 |
| K152220 | 2015-09-03 |
| K141101 | 2014-08-08 |
| K141403 | 2014-08-07 |
| K131473 | 2013-10-24 |
| K131081 | 2013-07-03 |
| K130256 | 2013-07-02 |
| K123573 | 2013-04-15 |
| K123168 | 2012-12-20 |
| K111592 | 2011-08-25 |
| K103539 | 2011-01-20 |
| K102749 | 2010-12-10 |
| K100558 | 2010-07-22 |
| K091909 | 2009-07-09 |
| K090962 | 2009-06-19 |
| K083613 | 2008-12-23 |
| K083207 | 2008-11-14 |
| K073549 | 2008-02-28 |
| K072034 | 2007-09-20 |
| K070805 | 2007-07-11 |
| K051113 | 2006-01-04 |
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.