Single Use Surgical Optical Fiber
Single use Surgical Ball tip Optical Fiber ø 272 µm. Distributed by Olympus Surgical Technologies America.Gyrus ACMI, Inc.
92manufacturers in China registered for this device type
70catalogue numbers in this listing
57510(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 | Quanta System Spa, Italy |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K180158 |
| Record published | 2016-08-29 |
| Record revised | 2022-10-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton box of 2, carton box of 5, carton of 5, carton of 2, pack of 5, pack of 2 |
| Distribution end date | 2023-06-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OAF402011 | In distribution | |
| OAF008001 | In distribution | |
| OAF002011 | In distribution | |
| OAF002091 | In distribution | |
| OAF005511 | In distribution | |
| OAF102711 | In distribution | |
| OAF103691 | In distribution | |
| OFA001511 | In distribution | |
| EMP-FBX272HS | In distribution | |
| OAF008011 | In distribution | |
| OAF703611 | In distribution | |
| EMP-FBX550HS | In distribution | |
| OAF004011 | In distribution | |
| OAF003611 | In distribution | |
| OAF009901 | In distribution | |
| EMP-FBX200BHS | In distribution | |
| OAF703691 | In distribution | |
| EMP-FBX365HS | In distribution | |
| OAF005501 | In distribution | |
| OAF302721 | In distribution | |
| OAF002791 | In distribution | |
| OAF006091 | In distribution | |
| OAF009911 | In distribution | |
| FSI272 | In distribution | |
| OAF006011 | In distribution | |
| OAF002701 | In distribution | |
| OAF004001 | In distribution | |
| OAF703601 | In distribution | |
| EMP-FBX200BHS-C | In distribution | |
| FSI800 | In distribution | |
| FSI200 | In distribution | |
| OAF006001 | In distribution | |
| EMP-FBX272HS-C | In distribution | |
| OAF102791 | In distribution | |
| OAF002711 | In distribution | |
| OAF003691 | In distribution | |
| OAF302711 | In distribution | |
| FSI000 | In distribution | |
| OAF702701 | In distribution | |
| EMP-FBX200HS | In distribution | |
| OAF702711 | In distribution | |
| OAF702791 | In distribution | |
| FSI550 | In distribution | |
| OAF402711 | In distribution | |
| OAF103611 | In distribution | |
| FSI365 | In distribution | |
| EMP-FBX1000HS | In distribution | |
| FBI272 | In distribution | |
| OAF003601 | In distribution | |
| TMS236740 | Withdrawn | |
| 09-0049 | Withdrawn | |
| OAF089901 | Withdrawn | |
| TMS236738 | Withdrawn | |
| OAF088001 | Withdrawn | |
| OFH302721 | Withdrawn | |
| TMS236742 | Withdrawn | |
| 09-0052 | Withdrawn | |
| OFH302711 | Withdrawn | |
| 09-0051 | Withdrawn | |
| OFH009911 | Withdrawn | |
| OFH703611 | Withdrawn | |
| OFH002011 | Withdrawn | |
| 09-0048 | Withdrawn | |
| TMS236739 | Withdrawn | |
| TMS236741 | Withdrawn | |
| OFH005511 | Withdrawn | |
| TMS236743 | Withdrawn | |
| OFH702711 | Withdrawn | |
| 09-0050 | Withdrawn | |
| OFH002711 | 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 |
| 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 |
|---|---|
| K240983 | 2025-06-06 |
| K243588 | 2025-02-19 |
| K241092 | 2024-10-10 |
| K242251 | 2024-09-03 |
| K232236 | 2023-10-20 |
| K223404 | 2023-01-20 |
| K220426 | 2022-03-16 |
| K211228 | 2022-02-02 |
| K210142 | 2021-03-11 |
| K202503 | 2020-11-18 |
| K202041 | 2020-10-15 |
| K201455 | 2020-06-30 |
| K200234 | 2020-02-25 |
| K192600 | 2020-02-21 |
| K192990 | 2019-12-20 |
| K191842 | 2019-09-17 |
| K192160 | 2019-09-06 |
| K182669 | 2018-10-17 |
| K181632 | 2018-09-17 |
| K180922 | 2018-05-08 |
| K180426 | 2018-03-16 |
| K180423 | 2018-03-15 |
| K180158 | 2018-02-14 |
| K173002 | 2017-12-13 |
| K172376 | 2017-10-19 |
| K172198 | 2017-10-17 |
| K172025 | 2017-07-31 |
| K171945 | 2017-07-28 |
| K171711 | 2017-07-07 |
| K170331 | 2017-03-03 |
| K163222 | 2016-12-05 |
| K163009 | 2016-12-01 |
| K160368 | 2016-04-05 |
| K160513 | 2016-03-18 |
| K152714 | 2015-12-21 |
| K152012 | 2015-12-08 |
| K151629 | 2015-10-27 |
| K152220 | 2015-09-03 |
| K141101 | 2014-08-08 |
| K141403 | 2014-08-07 |
| K131473 | 2013-10-24 |
| K131081 | 2013-07-03 |
| K130256 | 2013-07-02 |
| K123573 | 2013-04-15 |
| K123168 | 2012-12-20 |
| K111592 | 2011-08-25 |
| K103539 | 2011-01-20 |
| K102749 | 2010-12-10 |
| K100558 | 2010-07-22 |
| K091909 | 2009-07-09 |
| K090962 | 2009-06-19 |
| K083613 | 2008-12-23 |
| K083207 | 2008-11-14 |
| K073549 | 2008-02-28 |
| K072034 | 2007-09-20 |
| K070805 | 2007-07-11 |
| K051113 | 2006-01-04 |
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 |
|---|---|---|---|---|---|---|---|
| Quanta System, S.P.A. | 510(k) number | 2021-04-27 | Class II | Process control | Product sterility is potentially compromised. | 26925 units | 2023-09-05 |
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.