SideFire® Directional Laser Probe
3.3mm Directional Laser Probe
92manufacturers in China registered for this device type
21catalogue numbers in this listing
16510(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 | Monteris Medical Corp, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-02 |
| Record revised | 2018-10-18 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Outer diameter 3.3 mm |
| Distribution end date | 2018-10-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20368-1 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-3 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-000 | Size 000 | Withdrawn |
| 20368-4 | Size 4 | Withdrawn |
| 20368-4 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-3 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-5 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-00 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-1 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-2 | Size 2 | Withdrawn |
| 20368-3 | Size 3 | Withdrawn |
| 20368-4 | Size 4 | Withdrawn |
| 20368-2 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-5 | Size 5 | Withdrawn |
| 20368-000 | Size 000 | Withdrawn |
| 20368-00 | Size 00 | Withdrawn |
| 20368-2 | Size 2 | Withdrawn |
| 20368-1 | Size 1 | Withdrawn |
| 20368-000 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-5 | Outer Diameter 3.3 mm | Withdrawn |
| 20368-00 | Size 00 | 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 |
|---|---|
| K231061 | 2023-12-08 |
| K222983 | 2023-03-15 |
| K201056 | 2020-08-21 |
| K193375 | 2020-01-03 |
| K182036 | 2018-10-15 |
| K173305 | 2017-11-17 |
| K172881 | 2017-10-20 |
| K171255 | 2017-07-25 |
| K170724 | 2017-04-07 |
| K162762 | 2016-10-26 |
| K143457 | 2015-02-19 |
| K141983 | 2014-08-11 |
| K131955 | 2013-07-30 |
| K131278 | 2013-07-11 |
| K120561 | 2013-04-01 |
| K081509 | 2009-05-01 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2017-10-05 | Class I | Device Design | The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. | 52 systems | 2021-01-21 |
| 2016-03-25 | Class I | Device Design | Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient’s brain. | 121 | 2017-03-10 |
| 2014-10-03 | Class II | Process control | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. | 133 devices | 2014-12-08 |
| 2014-10-03 | Class II | Process control | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. | 234 devices | 2014-12-08 |
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.