Optiscan Prime
OptiScan PRIME is a scanning delivery attachment for compatible Youlaser PRIME laser systems. It directs laser energy in a selected pattern for fractional skin resurfacing. With the…
OptiScan PRIME is a scanning delivery attachment for compatible Youlaser PRIME laser systems. It directs laser energy in a selected pattern for fractional skin resurfacing. With the appropriate laser configuration, it supports ablative resurfacing at 10,600 nm or fractional resurfacing and soft tissue coagulation at 1,550 nm.
The scanner attaches to the laser’s articulated delivery arm. Its touchscreen allows the operator to select the scan pattern, shape and dimensions. The scanning area can extend to 18 mm by 18 mm, with a specified 0.25 mm spot size.
Compatible Laser Modes
The scanner is used with the specified Youlaser PRIME, PRIME CO2 or PRIME MT configuration. Combined 10,600 nm and 1,550 nm delivery is supported with PRIME MT. Laser emission is activated through the connected system’s footswitch.
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) | K241092 |
| Record published | 2025-11-05 |
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 |
|---|---|---|
| OAM001886 | 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.