K-Laser
by Eltech S.R.L
510(k) K120604
K-Laser is a Class II device made by Eltech S.R.L, cleared under FDA 510(k) K120604 on 25 May 2012, 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 | NumberK120604 | Date25 May 2012 | StatusActive |
Official records
- FDA 510(k) database K120604
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILY
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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