Slimline SIS 200 Fiber
Catalogue number Slimline SIS 200 Fiber, listed by Lumenis, Ltd., Israel, 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
60510(k) clearances naming this product code
9recalls 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 | Lumenis, Ltd., Israel |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-08-22 |
| Record revised | 2026-01-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 3 |
| Distribution end date | 2026-01-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Slimline SIS 200 Fiber | 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 |
|---|---|
| K211979 | 2022-06-21 |
| K212703 | 2021-10-19 |
| K203544 | 2020-12-24 |
| K202428 | 2020-10-22 |
| K201663 | 2020-07-16 |
| K193500 | 2020-01-16 |
| K180597 | 2018-04-03 |
| K170179 | 2017-09-18 |
| K170060 | 2017-08-09 |
| K170121 | 2017-05-22 |
| K162837 | 2017-02-28 |
| K151109 | 2015-10-30 |
| K151947 | 2015-08-12 |
| K151331 | 2015-06-30 |
| K142860 | 2015-01-21 |
| K133319 | 2014-03-20 |
| K140388 | 2014-03-14 |
| K130164 | 2013-03-24 |
| K111213 | 2011-07-25 |
| K100415 | 2010-04-21 |
| K100384 | 2010-04-12 |
| K100228 | 2010-02-24 |
| K083733 | 2009-05-04 |
| K082809 | 2008-12-18 |
| K081704 | 2008-09-11 |
| K060448 | 2006-07-06 |
| K053628 | 2006-04-07 |
| K060338 | 2006-03-09 |
| K052526 | 2005-11-15 |
| K052129 | 2005-08-30 |
| K043173 | 2005-01-31 |
| K040270 | 2004-12-16 |
| K032357 | 2003-10-09 |
| K030033 | 2003-07-21 |
| K030342 | 2003-07-17 |
| K024093 | 2003-06-19 |
| K030527 | 2003-05-20 |
| K030147 | 2003-04-15 |
| K022060 | 2002-10-30 |
| K022327 | 2002-10-16 |
| K020839 | 2002-10-11 |
| K022181 | 2002-10-01 |
| K011703 | 2001-08-29 |
| K004006 | 2001-03-26 |
| K000498 | 2000-03-13 |
| K991258 | 1999-05-13 |
| K990947 | 1999-04-27 |
| K980685 | 1998-05-20 |
| K974789 | 1998-03-09 |
| K973470 | 1997-12-09 |
| K972347 | 1997-09-19 |
| K960413 | 1996-04-04 |
| K951812 | 1995-07-07 |
| K946304 | 1995-03-15 |
| K933318 | 1994-07-08 |
| K903689 | 1990-09-20 |
| K902470 | 1990-07-26 |
| K895518 | 1989-11-30 |
| K895143 | 1989-09-25 |
| K820327 | 1982-03-08 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2025-07-22 | Class II | Nonconforming Material/Component | The potential for unsterilized product within finished product labeled as sterile. | 13 units | |
| 2025-01-23 | Class II | Under Investigation by firm | The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on. | 3 devices | |
| 2016-09-25 | Class II | Software Manufacturing/Software Deployment | The cleaning instructions provided in FemTouch Operator’s Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. | 69 units | 2017-04-11 |
| 2015-11-17 | Class II | Device Design | Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device. | 33 filters | 2016-11-30 |
| 2015-03-25 | Class II | Software design | Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin t | 117 units | 2016-06-15 |
| 2006-08-29 | Not classified | Other | Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use. | 10,815 | 2007-01-22 |
| 2006-02-09 | Not classified | Other | During hair removal treatment, patients’ skin can experience burns due to debris accumulating on the sapphire crystal tip. | 3,426 units | 2006-08-28 |
| 2006-02-01 | Not classified | Other | The BP/Notch filter may be out of specification and may cause injury to the patient’s eye due to high power (energy) delivered by the Laser System during medical procedures. | Approx. 1436 units | 2006-12-21 |
| 2005-04-08 | Not classified | Other | Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns. | 142 units | 2006-12-28 |
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.