Super Veloce
510(k) K241699
Super Veloce is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Ilooda.co., Ltd, cleared under FDA 510(k) K241699 on 13 Aug 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241699 | Date13 Aug 2024 | StatusActive |
Official records
- FDA 510(k) database K241699
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Ilooda Co,., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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