Lithoblast Single-Use Holmium Laser Fibers

LithoBlast is a single-use fibreoptic delivery device for compatible Ho:YAG surgical lasers. A proximal SMA 905 connector attaches to the laser, and the fibre transmits energy forward…

Registry build 21.09.26

LithoBlast is a single-use fibreoptic delivery device for compatible Ho:YAG surgical lasers. A proximal SMA 905 connector attaches to the laser, and the fibre transmits energy forward through a flat-cleaved distal tip.

The fibres are 300 cm long and available in four core diameters: 272, 365, 550 and 940 micrometres. Their straight exposed distal section is 10 mm long.

Listed Item

365 µm Laser Fiber Blast Shield A

Connector and Grip Formats

A stress boot and ABS over-nut sleeve support handling at the connector. Sleeve styles include narrow straight, indented finger-grip and projecting finger-grip forms. Compatible Ho:YAG laser configurations and permitted power depend on the fibre model.

92manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code GEX
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

Regulatory record for Lithoblast Single-Use Holmium Laser Fibers
Listed by Dawell Medical, LLC, United States
FDA product code GEX
Device type Powered Laser Surgical Instrument
Device class Class 2
Regulation 21 CFR 878.4810
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K250776
Record published 2026-03-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Base package of 5, basse package of 5, pack of 5
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Lithoblast Single-Use Holmium Laser Fibers
Catalogue number Size Status
LB365BH-AG-A In distribution
LB550BH-REG-B In distribution
LB550BH-AG-C In distribution
LB365BH-BS-A In distribution
LB272BH-BS-A In distribution
LB550BH-BS-B In distribution
LB272BH-BS-B In distribution
LB365BH-REG-C In distribution
LB940BH-REG-A In distribution
LB365BH-AG-B In distribution
LB365BH-AG-C In distribution
LB940BH-REG-C In distribution
LB550BH-REG-A In distribution
LB272BH-REG-A In distribution
LB272BH-REG-B In distribution
LB272BH-REG-C In distribution
LB940BH-REG-B In distribution
LB550BH-BS-A In distribution
LB550BH-AG-A In distribution
LB550BH-BS-C In distribution
LB272BH-AG-B In distribution
LB940BH-AG-C In distribution
LB365BH-BS-B In distribution
LB940BH-AG-A In distribution
LB272BH-AG-A In distribution
LB550BH-REG-C In distribution
LB365BH-BS-C In distribution
LB365BH-REG-B In distribution
LB550BH-AG-B In distribution
LB272BH-BS-C In distribution
LB272BH-AG-C In distribution
LB940BH-AG-B In distribution
LB365BH-REG-A In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K250776 2025-10-14

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer