Soltive
SOLTIVE SuperPulsed Laser Fiber 200 Micron Ball Tip Fiber (5/PK)
92manufacturers in China registered for this device type
25catalogue numbers in this listing
2510(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 | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K242191 |
| Record published | 2020-03-23 |
| Record revised | 2025-06-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 270 to 272 °F |
| Packaging | Pack of 5 |
| Distribution end date | 2025-03-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TFL-AVC | In distribution | |
| TFL-FBX550S | In distribution | |
| TFL-AFS 200 | In distribution | |
| TFL-AFSW | In distribution | |
| TFL-AVCA | In distribution | |
| TFL-FBX150S | In distribution | |
| TFL-AFSWL | In distribution | |
| TFL-FBX200BS | In distribution | |
| TFL-CPLU | In distribution | |
| TFL-AWS | In distribution | |
| TFL-SLS | In distribution | |
| TFL-AFS 550 | In distribution | |
| TFL-FBX150BS | In distribution | |
| TFL-AIC | In distribution | |
| TFL-PLS | In distribution | |
| TFL-FBX200S | In distribution | |
| TFL-FBX940S | In distribution | |
| TFL-FBX365S | In distribution | |
| TFL-APCEU | In distribution | |
| TFL-AFS 365 | In distribution | |
| TFL-FBX940R | In distribution | |
| TFL-AFS 940 | In distribution | |
| TFL-APCUS | In distribution | |
| TFL-CSLU | In distribution | |
| TFL-AFC | 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 |
|---|---|
| K221306 | 2023-01-27 |
| K211401 | 2021-06-03 |
Recalls Naming This Product
16 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2026-02-27 | Class II | Process control | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By desi | 408 units |
| Olympus Corporation of the Americas | 510(k) number | 2026-02-27 | Class II | Process control | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By desi | 32 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-05-06 | Class II | Under Investigation by firm | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents. | 201 units (100 US, 101 OUS) |
| Olympus Corporation of the Americas | 510(k) number | 2025-05-06 | Class II | Under Investigation by firm | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents. | 1549 units (1025 US, 524 OUS) |
| Olympus Corporation of the Americas | 510(k) number | 2025-05-06 | Class II | Under Investigation by firm | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents. | 551,154 units (417859 US, 133710 OUS) |
| Olympus Corporation of the Americas | 510(k) number | 2025-05-06 | Class II | Under Investigation by firm | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents. | 2,675 units (190 US, 2485 OUS) |
| Olympus Corporation of the Americas | 510(k) number | 2025-04-04 | Class II | Unknown/Undetermined by firm | Preset treatment parameters are not consistently being used in accordance with the IFU. | 189 |
| Olympus Corporation of the Americas | UDI-DI | 2024-08-13 | Class II | Under Investigation by firm | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients | 1373 units |
| Olympus Corporation of the Americas | UDI-DI | 2024-08-13 | Class II | Under Investigation by firm | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients | 159 units |
| Olympus Corporation of the Americas | UDI-DI | 2024-05-31 | Class II | Device Design | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. | 1,585 Units |
| Olympus Corporation of the Americas | UDI-DI | 2024-05-31 | Class II | Device Design | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. | 253 Units |
| Olympus Corporation of the Americas | UDI-DI | 2024-05-31 | Class II | Device Design | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. | 1,838 Units |
| Olympus Corporation of the Americas | UDI-DI | 2024-01-29 | Class II | Under Investigation by firm | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. | 17 Units (OUS Only) |
| Olympus Corporation of the Americas | UDI-DI | 2024-01-29 | Class II | Under Investigation by firm | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. | 203 Units (OUS Only) |
| Olympus Corporation of the Americas | UDI-DI | 2023-12-04 | Class II | Under Investigation by firm | Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient). | 179 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-12-01 | Class II | Labeling Change Control | Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, whic | 82,200 total units (5 per box) |
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.