K242755
- 510(k) number
- K242755
- Device name
- Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
- Applicant
- Gigaalaser Company , Ltd. CN
- Product code
- ILY — Lamp, Infrared, Therapeutic Heating
- Decision date
- 2025-05-19
- Date received
- 2024-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242755.pdf
Official FDA record: K242755
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.