Identifiers
- 510(k) Number
- K211335 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diode Laser Machine BM-100 is a medical device classified as a diode laser system (Product Code: GEX) designed for surgical and cosmetic procedures. It emits coherent light at specific wavelengths to achieve tissue ablation, coagulation, or vaporisation, commonly used in dermatological, plastic surgery, and general surgical applications. Its laser output is intended for precise cutting, marking, or removal of tissue while minimising thermal damage to surrounding areas.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals, surgical centres, or dermatology clinics. The BM-100 operates under FDA clearance (510K, K211335) as substantially equivalent to predicate devices, with regulatory oversight by the Surgical, Urological, and Gynaecological Devices Advisory Committee. Sterilisation and maintenance protocols must adhere to standard medical device guidelines, and its use requires compliance with manufacturer instructions for safety and performance. No MRI safety information or single-use designation is specified.
Frequently asked questions
What is the BM-100 Diode Laser Machine used for?
The BM-100 Diode Laser Machine is designed for surgical and cosmetic procedures, emitting coherent light at specific wavelengths to perform tissue ablation, coagulation, or vaporisation. It is commonly used in dermatology, plastic surgery, and general surgery to achieve precise cutting, marking, or removal of tissue while minimising thermal damage to surrounding areas.
Is the BM-100 Diode Laser Machine reusable or single-use?
The BM-100 is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals, surgical centres, or dermatology clinics. Reusability requires adherence to strict sterilisation and maintenance protocols as outlined by the manufacturer to ensure safety and performance.
What regulatory clearance does the BM-100 Diode Laser Machine hold?
The BM-100 Diode Laser Machine holds FDA clearance under the 510(k) pathway, specifically clearance number K211335. It is classified as substantially equivalent to predicate devices and falls under the Surgical, Urological, and Gynaecological Devices Advisory Committee’s oversight.
What advisory committee reviewed the BM-100 Diode Laser Machine?
The BM-100 Diode Laser Machine was reviewed by the Surgical, Urological, and Gynaecological Devices Advisory Committee (SU). This committee provides advisory input on devices related to general, plastic surgery, and other surgical applications.
Does the BM-100 Diode Laser Machine require special storage conditions?
While specific storage conditions are not detailed in the provided data, reusable medical devices like the BM-100 generally require clean, dry, and controlled environments to prevent contamination and ensure longevity. Follow the manufacturer’s instructions for proper storage and maintenance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211335 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhengzhou Bestview ST Co., Ltd.
Sources (1)
- FDA 510(k) K211335 24 fields · synced Oct 1, 2026