K242755 is an FDA 510(k) clearance for the Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B). This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Gigaalaser Company , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on May 19, 2025, 249 days after receiving the submission on September 12, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K242755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2024 |
| Decision Date | May 19, 2025 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ILY - Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |