Waterlase Iplus Dental Laser System
A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a…
A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
92manufacturers in China registered for this device type
53catalogue numbers in this listing
33510(k) clearances naming this product code
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 | Biolase Technology, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K210183 |
| Record published | 2023-06-19 |
| Record revised | 2023-06-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 20 to 80 % RH |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| All tissue YSGG dental laser system , midnight blue w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, aquarium premier | In distribution | |
| All tissue YSGG dental laser system, jungle w/ C&V indication | In distribution | |
| 7200854-011 Refurbished | In distribution | |
| All tissue YSGG dental laser system, purple w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system , bright lime, w/ C&V indication | In distribution | |
| 7200854-03 | In distribution | |
| All tissue YSGG dental laser system , bright lime premier | In distribution | |
| 7200854-01 Refurbished | In distribution | |
| 7200854-012 Refurbished | In distribution | |
| 7200854-14 | In distribution | |
| All tissue YSGG dental laser system, platinum, premier | In distribution | |
| All tissue YSGG dental laser system,pearl white, premier | In distribution | |
| All tissue YSGG dental laser system, yellow w/ C&V indication | In distribution | |
| All Tissue YSGG dental laser system, racing red w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, racing red premier | In distribution | |
| 7200854-013 Refurbished | In distribution | |
| All tissue YSGG dental laser system, burnt orange premier | In distribution | |
| All tissue YSGG dental laser system,pearl white with C&V indication | In distribution | |
| All tissue YSGG dental laser system, jungle premier | In distribution | |
| 7200854-07 | In distribution | |
| LaserFresh Accessory Kit Bundle | In distribution | |
| Fractional Handpiece Kit | In distribution | |
| All tissue YSGG dental laser system, purple w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, rose gold w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, gloss black premier | In distribution | |
| 7200854-04 Refurbished | In distribution | |
| 7200854-09 Refurbished | In distribution | |
| 7200854-07 Refurbished | In distribution | |
| 7200854-02 | In distribution | |
| All tissue YSGG dental laser system, rose gold premier | In distribution | |
| All tissue YSGG dental laser system, burnt orange w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, zebra w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, fish w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system , midnight blue premier | In distribution | |
| All tissue YSGG dental laser system, yellow premier | In distribution | |
| 7200854-12 | In distribution | |
| All tissue YSGG dental laser system, aquarium w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, gloss black w/ C&V indication | In distribution | |
| All tissue YSGG dental laser system, platinum, w/ C&V indication | In distribution | |
| 7200854-05 | In distribution | |
| 7200854-03 Refurbished | In distribution | |
| 7200854-13 | In distribution | |
| Fractional Handpiece Kit | In distribution | |
| 7200854-09 | In distribution | |
| 7200854-02 Refurbished | In distribution | |
| 7200854-014 Refurbished | In distribution | |
| All tissue YSGG dental laser system, platinum SG2 | In distribution | |
| All tissue YSGG dental laser system, red SG2 | In distribution | |
| 7200854-05 Refurbished | In distribution | |
| 7200854-04 | In distribution | |
| 7200854-11 | In distribution | |
| 7200854-01 | 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 |
| Leoni™ | Weinert Fiber Optics Inc. | 49 |
| LightScalpel | Lightscalpel Inc | 47 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210183 | 2022-04-21 |
| K193486 | 2020-03-16 |
| K192430 | 2019-12-04 |
| K190319 | 2019-10-10 |
| K172771 | 2017-11-29 |
| K163128 | 2017-01-11 |
| K161669 | 2016-07-28 |
| K141975 | 2015-03-05 |
| K140120 | 2014-10-10 |
| K122368 | 2013-05-02 |
| K130465 | 2013-04-11 |
| K121327 | 2013-02-01 |
| K121286 | 2012-09-28 |
| K101658 | 2010-08-11 |
| K093852 | 2010-03-12 |
| K091746 | 2009-12-07 |
| K083927 | 2009-10-01 |
| K091922 | 2009-07-14 |
| K090181 | 2009-02-11 |
| K082938 | 2008-12-22 |
| K083069 | 2008-11-13 |
| K081589 | 2008-06-13 |
| K071363 | 2008-02-12 |
| K071734 | 2008-01-25 |
| K061898 | 2007-01-26 |
| K052354 | 2006-07-05 |
| K031140 | 2004-07-07 |
| K030523 | 2004-01-30 |
| K030539 | 2003-10-10 |
| K011041 | 2001-07-03 |
| K003385 | 2001-01-25 |
| K991994 | 1999-09-10 |
| K950248 | 1995-02-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biolase MG LLC | 510(k) number | 2014-06-12 | Class II | Under Investigation by firm | Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF. | 117 units | 2014-10-06 |
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.