Photon Therapy Apparatus BL-10
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243993 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 Photon Therapy Apparatus BL-10 is a powered laser surgical instrument designed for tissue ablation, coagulation, or vaporisation in surgical procedures. Classified under the GEX product code, it operates using laser technology to deliver precise energy for medical interventions across general and plastic surgery applications.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K243993) as a Class II device under Special Controls. It is intended for use in controlled clinical settings, adhering to standard laser safety protocols, and requires proper maintenance and calibration to ensure reliable performance. No additional sterility or MRI safety information is specified in the provided data.
Frequently asked questions
What types of surgical procedures is the Photon Therapy Apparatus (BL-10) intended to assist with, and how does it achieve this?
The Photon Therapy Apparatus (BL-10) is designed for use in general and plastic surgery to perform tissue ablation, coagulation, or vaporisation. It achieves this by delivering precise laser energy, allowing surgeons to target and modify tissue with controlled precision during surgical interventions.
Is the Photon Therapy Apparatus (BL-10) a single-use or reusable device, and what maintenance is required to ensure proper function?
The Photon Therapy Apparatus (BL-10) is a reusable medical instrument. To ensure reliable performance, it requires proper maintenance and calibration, as outlined in the manufacturer’s guidelines, to comply with laser safety protocols and operational standards.
How is the Photon Therapy Apparatus (BL-10) regulated in the U.S., and what does this mean for its use in clinical settings?
The Photon Therapy Apparatus (BL-10) is regulated under the FDA’s 510(k) clearance process (K243993) as a Class II device under Special Controls. This means it has been deemed substantially equivalent to a legally marketed predicate device and must be used in controlled clinical settings while adhering to standard laser safety protocols.
What safety considerations should clinicians keep in mind when using the Photon Therapy Apparatus (BL-10) in their operating room?
Since the Photon Therapy Apparatus (BL-10) operates using laser technology, clinicians must follow standard laser safety protocols to prevent unintended exposure or damage. This includes ensuring proper shielding, training staff on safe handling, and maintaining the device according to manufacturer instructions to avoid performance risks.
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. Sources consulted: Photon Therapy Apparatus (BL-10) (K243993) — FDA 510 (k) | Innolitics, K243993 - Photon Therapy Apparatus (BL-10) - FDA 510 (k), 510(k) Premarket Notification, K243993 · Predicate Devices · Benchmed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243993 | Class II | Active |
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Manufacturer
- Manufacturer
- Xemis Medical Technology (Shenzhen) Co., Ltd.
Sources (1)
- FDA 510(k) K243993 24 fields · synced Oct 6, 2026