Accu-Beam
Accu-Beam is TTI Medical’s range of laser-delivery accessories, including reusable fibreoptic handpieces and CO₂ laser attachments. The fibreoptic handpieces hold a laser fibre or hollow…
Accu-Beam is TTI Medical’s range of laser-delivery accessories, including reusable fibreoptic handpieces and CO₂ laser attachments. The fibreoptic handpieces hold a laser fibre or hollow waveguide so the clinician can guide it to the treatment site.
The laser supplies the energy; the handpiece provides the mechanical interface for handling and positioning the delivery fibre. The range includes rigid forms, bendable handpieces and versions with suction. The listed 1059702 kit is one example within the wider Accu-Beam family.
Listed Item
Kit of 13 Weighted Fiber Handpieces. Included UDIs are: +B17710597800 +B17710597810 +B17710597820 +B17710597830 +B17710597840 +B17710597850 +B17710597860 +B17710597870 +B17710597880 +B17710597890 +B17710597900 +B17710597920 +B17710597930
Design and Use
Malleable handpieces can be reshaped during a procedure. Suction versions add a separate channel for smoke removal, while selected tips support tissue manipulation. The manufacturer lists fibreoptic handpieces for general surgery, orthopaedics, neurosurgery, ENT and oral surgery.
Separate CO₂ focusing attachments are described for incision, coagulation and ablation. These functions belong to their respective models; the component list establishes which accessories a particular kit contains.
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 | Transamerican Technologies International, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K952006 |
| Record published | 2016-05-24 |
| Record revised | 2025-08-15 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Pack of 10 |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9132 | In distribution | ||
| ACB-16 | In distribution | ||
| 9112B-13 | In distribution | ||
| 9199 | In distribution | ||
| 9152 | In distribution | ||
| 9205-17 | In distribution | ||
| 1059793 | In distribution | ||
| 9198 | In distribution | ||
| 9111 | In distribution | ||
| 096088 | In distribution | ||
| 9122 | In distribution | ||
| 9162-16 | In distribution | ||
| 1059740 | In distribution | ||
| 6200 | In distribution | ||
| 1059781 | In distribution | ||
| 9196 | In distribution | ||
| 9111B-13 | In distribution | ||
| AC-90mm M | In distribution | ||
| 1059782 | In distribution | ||
| 1059792 | In distribution | ||
| 9112B-12 | In distribution | ||
| 9192 | In distribution | ||
| 1059789 | In distribution | ||
| 096129 | In distribution | ||
| 9114B | In distribution | ||
| 1056521R-Kit | In distribution | ||
| 1059803 | In distribution | ||
| 9111-0203 | In distribution | ||
| 9171 | In distribution | ||
| 6151 | In distribution | ||
| 1059784 | In distribution | ||
| 6201 | In distribution | ||
| 1059791 | In distribution | ||
| 6202 | In distribution | ||
| 9113B-14 | In distribution | ||
| 9209 | In distribution | ||
| 9114-17-15 | In distribution | ||
| AC-330mm R | In distribution | ||
| 9204 | In distribution | ||
| 31260-455L | In distribution | ||
| 9111-0201 | In distribution | ||
| 9111B | In distribution | ||
| 1059761 | In distribution | ||
| 31260-532L | In distribution | ||
| 9197 | In distribution | ||
| 9185-2B-DW | In distribution | ||
| 1059711 | In distribution | ||
| ACB-11/12 | In distribution | ||
| 9185-2BS | In distribution | ||
| 6104 | In distribution | ||
| 9205 | In distribution | ||
| 1059712 | In distribution | ||
| 1059730 | In distribution | ||
| 9206-17 | In distribution | ||
| 1059783 | In distribution | ||
| 9172 | In distribution | ||
| 9112-14 | In distribution | ||
| 9211-01 | In distribution | ||
| 0010-0853T | In distribution | ||
| 6202-1 | In distribution | ||
| ACB-14 | In distribution | ||
| 9111-14 | In distribution | ||
| 9154B | In distribution | ||
| 9113B-13 | In distribution | ||
| 096087 | In distribution | ||
| 9112B | In distribution | ||
| 0010-0991T | In distribution | ||
| 1059801 | In distribution | ||
| 9112 | In distribution | ||
| 096081 | In distribution | ||
| 1059739 | In distribution | ||
| 9163-14 | In distribution | ||
| 9111-0202 | In distribution | ||
| 096084 | In distribution | ||
| 9111-13 | In distribution | ||
| 0010-0852P | In distribution | ||
| 9123 | In distribution | ||
| 9111B-14 | In distribution | ||
| 6103 | In distribution | ||
| 1059785 | In distribution | ||
| 9207 | In distribution | ||
| 9153 | In distribution | ||
| 9202 | In distribution | ||
| 1059745 | In distribution | ||
| 9190 | In distribution | ||
| 9209-17 | In distribution | ||
| 1059721 | In distribution | ||
| 1056521M-Kit | In distribution | ||
| 31260-455Z | In distribution | ||
| 31260-532Z | In distribution | ||
| 9194 | In distribution | ||
| 9113-14 | In distribution | ||
| 9202-17 | In distribution | ||
| 9185-1BS | In distribution | ||
| 9185-2B | In distribution | ||
| 9113B | In distribution | ||
| 1059738 | In distribution | ||
| 096606 | In distribution | ||
| 1059800 | In distribution | ||
| 91010 | In distribution | ||
| 1059770 | In distribution | ||
| 096086 | In distribution | ||
| 9208-17 | In distribution | ||
| 9203-17 | In distribution | ||
| 9206 | In distribution | ||
| 9113 | In distribution | ||
| 9115-13 | In distribution | ||
| 9191 | In distribution | ||
| 9203 | In distribution | ||
| 1059702 | In distribution | ||
| 096083 | In distribution | ||
| 1059780 | In distribution | ||
| 9114B-14 | In distribution | ||
| 9111B-12 | In distribution | ||
| 9131 | In distribution | ||
| 6109 | In distribution | ||
| 9121 | In distribution | ||
| 6200-2 | In distribution | ||
| 0010-0852T | In distribution | ||
| 096085 | In distribution | ||
| 1059786 | In distribution | ||
| 0010-0853P | In distribution | ||
| 1059788 | In distribution | ||
| 1059751 | In distribution | ||
| 096128 | In distribution | ||
| 6201-1 | In distribution | ||
| 9185-1S | In distribution | ||
| 9208 | In distribution | ||
| AC-300mm M | In distribution | ||
| 6150 | In distribution | ||
| 9183 | In distribution | ||
| 096082 | In distribution | ||
| 9211 | In distribution | ||
| 6108 | In distribution | ||
| 1059742 | In distribution | ||
| 9162-14 | In distribution | ||
| 1059750 | In distribution | ||
| 9204-17 | In distribution | ||
| AC-140mm M | In distribution | ||
| 1056522G-Kit | In distribution | ||
| 9151 | In distribution | ||
| 1059790 | In distribution | ||
| AC-240mm M | In distribution | ||
| 9112-13 | In distribution | ||
| 6105 | In distribution | ||
| 9114 | In distribution | ||
| 1059804 | In distribution | ||
| 1059787 | In distribution | ||
| 9155 | In distribution | ||
| 9182 | In distribution | ||
| 9193 | In distribution | ||
| 1059805 | In distribution | ||
| 9207-17 | In distribution | ||
| 1059802 | In distribution | ||
| 9154 | In distribution | ||
| SA-1059751 | In distribution | ||
| 9141 | In distribution | ||
| 9181 | In distribution | ||
| 096089 | In distribution | ||
| 9112B-14 | In distribution | ||
| 1059723 | In distribution | ||
| 9152B | In distribution | ||
| 9185-OTO | In distribution | ||
| 9195 | In distribution | ||
| 9111-0202 | 10 | Withdrawn | |
| 31226-02B | Withdrawn | ||
| 31260-02B | Withdrawn | ||
| 9111-0201 | 10 | Withdrawn | |
| 9111-0231 | 10 | Withdrawn | |
| 205-023-3 | 10 | Withdrawn | |
| 9111-0232 | 10 | Withdrawn | |
| 9111-0233 | 10 | Withdrawn | |
| 9171 | Withdrawn | ||
| 205-023-1 | 10 | Withdrawn | |
| 205-023-3 | 100 | Withdrawn | |
| 205-023-3 | Withdrawn | ||
| 205-023-5 | 10 | Withdrawn | |
| 9111-0203 | 10 | Withdrawn | |
| FOR-9702 | Withdrawn | ||
| 205-023-1 | Withdrawn | ||
| 205-023-5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| LightScalpel | Lightscalpel Inc | 47 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963193 | 1996-11-13 |
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.