PicoWay Laser System
PicoWay is a solid-state laser platform that delivers picosecond pulses to the skin for tattoo and benign pigmented-lesion treatment. Available wavelength options are 532, 730, 785 and 1064…
PicoWay is a solid-state laser platform that delivers picosecond pulses to the skin for tattoo and benign pigmented-lesion treatment. Available wavelength options are 532, 730, 785 and 1064 nm, with indications depending on wavelength and handpiece.
Pulse durations range from 240 to 500 picoseconds. An articulated arm and interchangeable handpieces deliver the light, with zoom handpieces providing 532 nm or 1064 nm output.
Patterned Handpieces
Resolve handpieces produce a 10-by-10 array of focused spots. The 532 nm Resolve Fusion design adds ring spots to the focused-spot array. The shared optical path supports delivery of 532 nm or 1064 nm energy, while the selected handpiece determines the supported treatment pattern.
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 | Candela Corporation, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K220853 |
| Record published | 2022-12-16 |
| Record revised | 2024-11-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-11-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9914-CH-9060 | In distribution | |
| 9914-JB-9060 | In distribution | |
| 9914-C1-9060 | Withdrawn | |
| 9914-C2-9060 | Withdrawn | |
| 9914-CH-9060 | Withdrawn |
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 |
|---|---|
| K230990 | 2023-06-01 |
| K220853 | 2022-10-13 |
| K212492 | 2021-12-20 |
| K201111 | 2020-05-26 |
| K191685 | 2019-09-16 |
| K183452 | 2019-02-01 |
| K150326 | 2015-04-16 |
| K140732 | 2014-11-07 |
| K140122 | 2014-05-09 |
| K133283 | 2013-12-26 |
| K112715 | 2011-10-05 |
| K111144 | 2011-07-18 |
| K081324 | 2008-06-17 |
| K073534 | 2008-04-03 |
| K071469 | 2007-08-15 |
| K063800 | 2007-02-05 |
| K063074 | 2006-12-27 |
| K063072 | 2006-12-20 |
| K063073 | 2006-12-20 |
| K051359 | 2005-07-13 |
| K050673 | 2005-06-13 |
| K043251 | 2005-02-09 |
| K041242 | 2004-11-22 |
| K033461 | 2004-01-16 |
| K033331 | 2004-01-16 |
| K030834 | 2003-12-03 |
| K033172 | 2003-10-30 |
| K030846 | 2003-09-16 |
| K024371 | 2003-03-31 |
| K024260 | 2003-03-21 |
| K022923 | 2003-03-13 |
| K024335 | 2003-03-12 |
| K022951 | 2003-01-27 |
| K022884 | 2003-01-22 |
| K023193 | 2002-12-20 |
| K014128 | 2002-10-04 |
| K021180 | 2002-07-02 |
| K020958 | 2002-06-21 |
| K013825 | 2002-02-15 |
| K013748 | 2002-02-11 |
| K013043 | 2001-10-11 |
| K011092 | 2001-07-09 |
| K010104 | 2001-04-11 |
| K002421 | 2000-11-03 |
| K001093 | 2000-09-19 |
| K001589 | 2000-08-18 |
| K994260 | 2000-05-26 |
| K993671 | 2000-01-24 |
| K984601 | 1999-02-04 |
| K981351 | 1998-07-13 |
| K974381 | 1998-02-10 |
| K972767 | 1997-12-04 |
| K861179 | 1986-11-20 |
Recalls
5 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2019-09-10 | Class II | Other | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules | in total 7,560 canisters (3240 additional as of 2/5/20) | 2020-10-20 |
| 2019-09-10 | Class II | Other | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules | in total 7,560 canisters (3240 additional as of 2/5/20) | 2020-10-20 |
| 2019-09-10 | Class II | Other | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules | 386 cases ( 15 pack canister/ case) (216 additional cases as | 2020-10-20 |
| 2019-09-10 | Class II | Other | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules | in total 7,560 canisters (3240 additional as of 2/5/20) | 2020-10-20 |
| 2013-11-06 | Class II | Software design | Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. | 1258 units | 2015-06-08 |
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.