VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B Medical Diode Laser Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242755 FDA 510(k)
- FDA Product Code
- ILY FDA 510(k)
- Models / Variants
- VELAS II-30B FDA 510(k)VELAS II-30A FDA 510(k)GBOX-15AB FDA 510(k)GBOX-20B FDA 510(k)CHEESE II-10B FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, and CHEESE II-10B are medical diode laser systems designed to emit infrared energy for therapeutic applications. These devices are classified as Physical Medicine Devices and are intended to deliver controlled thermal energy to elevate tissue temperature. Their primary function is to provide temporary relief of minor muscle and joint pain, reduce muscle spasms, and alleviate stiffness associated with minor arthritis. The systems promote relaxation of muscle tissue through targeted thermal stimulation.
These laser systems are supplied as reusable medical devices and are intended for use in clinical settings by trained professionals. They are not single-use and require proper maintenance and sterilization procedures as outlined in the manufacturer’s instructions. The devices are approved under FDA 510K clearance (K242755) and fall under the ILY product code for infrared-emitting devices. Storage and handling must comply with regulatory guidelines to ensure safety and performance integrity.
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: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB ..., VELAS Medical Diode Laser Systems - gigaamedical.com, Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242755 | Class II | Active |
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Manufacturer
- Manufacturer
- Gigaalaser Company Ltd.
- FDA Applicant
- Gigaalaser Company , Ltd.
Sources (1)
- FDA 510(k) K242755 24 fields · synced Sep 20, 2026