CoolTouch Ctev
Catalogue number R7300-0058, listed by New Star Lasers, Inc., United States, under Powered Laser Surgical Instrument. 92 manufacturers in China are registered for this product code.
92manufacturers in China registered for this device type
1catalogue number
27510(k) clearances naming this product code
4recalls on this 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 | New Star Lasers, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Record published | 2016-09-20 |
| Record revised | 2020-08-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2018-09-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R7300-0058 | Withdrawn |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 |
|---|---|
| K142286 | 2014-10-31 |
| K132607 | 2014-03-21 |
| K101783 | 2010-09-13 |
| K092964 | 2009-12-11 |
| K090410 | 2009-03-27 |
| K081628 | 2008-06-20 |
| K080163 | 2008-04-10 |
| K072751 | 2008-01-02 |
| K072424 | 2007-10-03 |
| K062210 | 2006-09-25 |
| K061618 | 2006-09-25 |
| K051434 | 2005-08-09 |
| K043046 | 2005-02-01 |
| K041323 | 2004-11-17 |
| K040131 | 2004-04-20 |
| K031954 | 2003-08-21 |
| K024259 | 2003-06-20 |
| K031184 | 2003-05-21 |
| K030453 | 2003-05-12 |
| K023962 | 2002-12-24 |
| K012982 | 2001-10-02 |
| K002347 | 2000-08-17 |
| K994273 | 2000-01-20 |
| K973764 | 1997-12-31 |
| K962791 | 1997-03-13 |
| K952489 | 1996-01-22 |
| K945156 | 1995-03-09 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2016-09-19 | Class II | Labeling False and Misleading | FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. | 17 systems | 2016-12-13 |
| 2016-09-19 | Class II | Labeling False and Misleading | FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. | 5 systems | 2016-12-13 |
| 2016-09-19 | Class II | Labeling False and Misleading | FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. | 44 systems CT3Plus; 47 systems CT3PZ | 2016-12-13 |
| 2015-05-13 | Class II | Software design (manufacturing process) | During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graph | 52 units | 2016-10-28 |
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.