Waterlase Laser Tips
A tip starter kit containing 5 different single-use tips intended for use with Waterlase laser delivery systems. The tips vary in core diameter and in length. The tips require sterilization…
A tip starter kit containing 5 different single-use tips intended for use with Waterlase laser delivery systems. The tips vary in core diameter and in length. The tips require sterilization prior to use.
92manufacturers in China registered for this device type
112catalogue 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) | K031140 |
| Record published | 2016-09-16 |
| Record revised | 2026-05-06 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Box of 5, box of 10, box of 3, box of 2, box of 30, box of 20 |
| Sizes | Length 2 to 33 mm; outer diameter 200 to 1200 µm; width 320 µm |
| Distribution end date | 2018-08-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RFPT8-14 | Length 14 mm | In distribution |
| Z4-28 | Length 28 mm | In distribution |
| MGG6-4 | Length 4 mm | In distribution |
| MG6-9 | Outer Diameter 600 µm | In distribution |
| RFPT5-14 | Outer Diameter 500 µm | In distribution |
| MZ3-14 | Outer Diameter 320 µm | In distribution |
| Z3-25 | Length 25 mm | In distribution |
| Z2-18 | Outer Diameter 200 µm | In distribution |
| MX Turbo Tips | Outer Diameter 1100 µm | In distribution |
| MZ3-9 | Length 9 mm | In distribution |
| Z2-22 | Outer Diameter 200 µm | In distribution |
| MZ Zip Tip Combo | Outer Diameter 500 µm | In distribution |
| MZ3 Combo | Outer Diameter 320 µm | In distribution |
| MZ3-28 | Outer Diameter 320 µm | In distribution |
| MZ8-6 ZipTips | Outer Diameter 800 µm | In distribution |
| MG6 | Outer Diameter 600 µm | In distribution |
| MZ10-6 Zip Tips | Length 6 mm | In distribution |
| MZ5-14 Zip Tips | Outer Diameter 500 µm | In distribution |
| MZ6-6 | Outer Diameter 600 µm | In distribution |
| MS75-6 | Outer Diameter 750 µm | In distribution |
| MZ6-9 | Outer Diameter 600 µm | In distribution |
| S75-6 | Outer Diameter 750 µm | In distribution |
| MG6-6 | Outer Diameter 600 µm | In distribution |
| Z2-28 | Outer Diameter 200 µm | In distribution |
| Z2-33 | Length 33 mm | In distribution |
| Z6-14 | Length 14 mm | In distribution |
| Radial Firing Endo Tips | Length 21 mm | In distribution |
| RFT2-21 | Outer Diameter 200 µm | In distribution |
| MZ3-22 | Length 22 mm | In distribution |
| MX11 | Outer Diameter 1100 µm | In distribution |
| Z2-20 | Length 20 mm | In distribution |
| 7000825 | In distribution | |
| Z4-20 | Outer Diameter 400 µm | In distribution |
| Z6-6 | Outer Diameter 600 µm | In distribution |
| G6-4 | Length 4 mm | In distribution |
| MZ5 Zip Tip Combo | Length 3 mm | In distribution |
| Radial Firing Perio Tips | Length 14 mm | In distribution |
| 7230001 | Length 21 mm | In distribution |
| MGG6-9 | Length 9 mm | In distribution |
| Side Firing Tips, SFT8-18 | Length 18 mm | In distribution |
| MC3-9 | Outer Diameter 320 µm | In distribution |
| MZ5-9 Zip Tips | Outer Diameter 500 µm | In distribution |
| LaserFresh Sapphire Tip, Single Bagged Tip, Single Use | Outer Diameter 1200 µm | In distribution |
| RFPT5-10 | Length 10 mm | In distribution |
| MZ5-6 Zip Tips | Outer Diameter 500 µm | In distribution |
| MZ5-3 Zip Tips | Outer Diameter 500 µm | In distribution |
| RFT3-21 | Length 21 mm | In distribution |
| MZ Zip Tip Combo | Outer Diameter 320 µm | In distribution |
| 7000404 | Length 14 mm | In distribution |
| Z3-22 | Outer Diameter 320 µm | In distribution |
| RFPT8-10 | Outer Diameter 800 µm | In distribution |
| Z3-20 | Length 20 mm | In distribution |
| Z4-14 | Outer Diameter 400 µm | In distribution |
| C6 | Length 4 mm | In distribution |
| MX Turbo Tips | Outer Diameter 700 µm | In distribution |
| MZ3-20 | Width 320 µm | In distribution |
| C12-9 | Length 9 mm | In distribution |
| Z3-18 | Outer Diameter 320 µm | In distribution |
| MC12-9 | Outer Diameter 1200 µm | In distribution |
| MZ Zip Tip Combo | Length 6 mm | In distribution |
| MZ6-12 | Outer Diameter 600 µm | In distribution |
| 7000402 | Length 25 mm | In distribution |
| Z4-18 | Length 18 mm | In distribution |
| RFT3-17 | Outer Diameter 320 µm | In distribution |
| MG6-4 | Outer Diameter 600 µm | In distribution |
| Starter Kit | In distribution | |
| MZ6-14 | Outer Diameter 600 µm | In distribution |
| C6-9 | Outer Diameter 600 µm | In distribution |
| MC6-9 | Outer Diameter 600 µm | In distribution |
| RFT2-17 | Outer Diameter 200 µm | In distribution |
| RFT2-25 | Length 25 mm | In distribution |
| 7200831 | In distribution | |
| C6-4, single | Length 4 mm | In distribution |
| MZ6-3 Zip Tips | Outer Diameter 600 µm | In distribution |
| Z3-28 | Outer Diameter 320 µm | In distribution |
| Z4-9 | Length 9 mm | In distribution |
| Z2-25 | Length 25 mm | In distribution |
| MZ3-18 | Length 18 mm | In distribution |
| 7000403 | Length 14 mm | In distribution |
| C Tip Combo | Length 9 mm | In distribution |
| MZ6-14 Zip Tips | Outer Diameter 600 µm | In distribution |
| Tip, MZ6-17mm | Outer Diameter 600 µm | In distribution |
| Z2-14 | Length 14 mm | In distribution |
| MZ Zip Tip Combo | Outer Diameter 500 µm | In distribution |
| G6-6 | Outer Diameter 600 µm | In distribution |
| Z3-14 | Length 14 mm | In distribution |
| MZ6-6 Zip Tips | Outer Diameter 600 µm | In distribution |
| MGG6-6 | Length 6 mm | In distribution |
| Sapphire Chisel Tips | Length 9 mm | In distribution |
| MX7 | Outer Diameter 700 µm | In distribution |
| G6 | Outer Diameter 600 µm | In distribution |
| MZ8-9 ZipTips | Outer Diameter 800 µm | In distribution |
| 7200107 | In distribution | |
| T4-6 | Outer Diameter 400 µm | In distribution |
| MX5 | Outer Diameter 500 µm | In distribution |
| G6-9 | Length 9 mm | In distribution |
| Z3-9 | Outer Diameter 320 µm | In distribution |
| C6-6, single | Length 6 mm | In distribution |
| Radial Firing Endo Tips | Outer Diameter 200 µm | In distribution |
| Z6-9 | Length 9 mm | In distribution |
| MZ6-9 Zip Tips | Outer Diameter 600 µm | In distribution |
| MZ10-9 Zip Tips | Length 9 mm | In distribution |
| Z4-25 | Outer Diameter 400 µm | In distribution |
| MZ6-4 | Outer Diameter 600 µm | In distribution |
| MX9 | Outer Diameter 900 µm | In distribution |
| Z4-22 | Length 22 mm | In distribution |
| C3-9 | Length 9 mm | In distribution |
| MZ3-25 | Outer Diameter 320 µm | In distribution |
| MT4-6 | Outer Diameter 400 µm | In distribution |
| 7200824 | Withdrawn | |
| MC6 | Length 6 mm | Withdrawn |
| Side Firing Tips | Outer Diameter 800 µm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 181 |
| Powered Laser Surgical Instrument | Weinert Fiber Optics Inc. | 117 |
| 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 |
| 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.