Diode Laser Tips
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns…
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use.
92manufacturers in China registered for this device type
37catalogue 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) | K121286 |
| Record published | 2016-09-16 |
| Record revised | 2023-06-12 (version 9) |
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 30, box of 20, box, box of 5, box of 10, box of 3 |
| Sizes | Outer diameter 200 to 400 µm; length 4 to 250 mm |
| Distribution end date | 2019-12-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZ Tips, Starter Kit | Outer Diameter 400 µm | In distribution |
| Perio EZ Tips Combo Pack, E4 | Length 9 mm | In distribution |
| Pre-Initiated, Perio, 4-9 | Length 9 mm | In distribution |
| PI Pro Tips, Surgical, 4-4 | Outer Diameter 400 µm | In distribution |
| Surgical EZ Tips | Outer Diameter 400 µm | In distribution |
| PI Pro Tips, Starter Kit | Outer Diameter 300 µm | In distribution |
| Epic Q, surgical assortment kit, 30PK | Length 4 mm | In distribution |
| Pre-initiated Surgical Assortment | In distribution | |
| E4-250 EZ Tips | Length 250 mm | In distribution |
| perio, E3-9, single tip | Length 9 mm | In distribution |
| Pre-initiated, Surgical, 3-4 | Outer Diameter 300 µm | In distribution |
| Pre-initiated, Perio, 4-7 | Outer Diameter 400 µm | In distribution |
| E2-20 EZ Tips | Length 20 mm | In distribution |
| E4-7 EZ Tips | Length 7 mm | In distribution |
| eztips, surgical assortment kit, 30PK | Length 4 mm | In distribution |
| E2-4 EZ Tips | Outer Diameter 200 µm | In distribution |
| E2-14 EZ Tips | Outer Diameter 200 µm | In distribution |
| Pre-Initiated, Perio, 3-9 | Length 9 mm | In distribution |
| E4-100 EZ Tips | Outer Diameter 400 µm | In distribution |
| E4-60 EZTip | Length 60 mm | In distribution |
| perio, E4-9, single tip | Length 9 mm | In distribution |
| Pre-initiated, Surgical, 4-4 | Length 4 mm | In distribution |
| E3-4 EZ Tips | Length 4 mm | In distribution |
| E4-4 EZ Tips | Length 4 mm | In distribution |
| Perio EZ Tips Combo Pack, E3 | Outer Diameter 300 µm | In distribution |
| Pre-initiated, Perio, 3-7 | Outer Diameter 300 µm | In distribution |
| PI Pro Tips, Surgical, 3-4 | Length 4 mm | In distribution |
| E3-7 EZ Tips | Outer Diameter 300 µm | In distribution |
| EpiTip 4-9 Perio | Outer Diameter 400 µm | Withdrawn |
| EpiTip 4-7 Perio | Length 7 mm | Withdrawn |
| EpiTip 3-9 Perio | Outer Diameter 300 µm | Withdrawn |
| EpiTip 3-4 Surgical | Length 4 mm | Withdrawn |
| EpiTips Surgical Assortment | Withdrawn | |
| Diode Laser Tips – Starter Kit | Length 9 mm | Withdrawn |
| EpiTip 4-4 Surgical | Outer Diameter 400 µm | Withdrawn |
| EpiTip 3-7 Perio | Length 7 mm | Withdrawn |
| Surgical EZ Tips | Length 100 mm | 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 |
|---|---|
| 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 |
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.