Adler MicroMed Laser Surgery Fiber
Adler MicroMed Laser Surgery Fiber transmits energy from a compatible surgical laser to tissue. Its silica quartz glass core supports wavelengths from 450 to 2100 nm and delivery in pulsed…
Adler MicroMed Laser Surgery Fiber transmits energy from a compatible surgical laser to tissue. Its silica quartz glass core supports wavelengths from 450 to 2100 nm and delivery in pulsed or continuous-wave modes.
Fibers range from 2 to 3 meters long and are supplied sterile for single use. Distal designs include capped and noncapped tips in shapes selected for the intended surgical application.
Listed Item
Adler MicroMed Laser Surgery Luer Lock Fiber 600 um NA 0.37 2.5m
Applications
Compatible laser applications include soft tissue incision, excision, vaporization, ablation, hemostasis and coagulation in open or endoscopic procedures. Contact and noncontact use is described, with the specific indication dependent on the compatible laser and fiber configuration.
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 | Adler Micromed, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K152417 |
| Record published | 2024-02-12 |
| Record revised | 2024-02-12 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 10 |
| Distribution end date | 2024-02-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 631000288 | In distribution | |
| SFCS000145 | In distribution | |
| 631000302 | In distribution | |
| BFCS000296 | In distribution | |
| 631000304 | In distribution | |
| 635000235 | In distribution | |
| SFCS000102 | In distribution | |
| 631000296 | In distribution | |
| BFCS000233 | In distribution | |
| BFCS000304 | In distribution | |
| 636000099 | In distribution | |
| SFCS000099 | Withdrawn | |
| BFCS000302 | Withdrawn | |
| SFCS000235 | 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 |
|---|---|
| K152417 | 2015-12-01 |
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.