510(k) clearance
ECHOLASER X4
- 510(k) number
- K261964
- Applicant
- Elesta S.P.A
- Decision date
- Aug 19, 2026
- Date received
- Jun 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GEX
- Device type
- Powered Laser Surgical Instrument
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Calenzano, IT