Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
FDA 510(k) clearance K242755 · decided 2025-05-19
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-12
- Decision date
- 2025-05-19
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Wuhan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.