510(k) K120604
K120604 is an FDA 510(k) premarket notification submitted by Eltech S.R.L for the device "K-LASER". The FDA issued a decision of Substantially Equivalent on May 25, 2012. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Eltech S.R.L has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2012
- Date Received
- Feb 28, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type
- 510(k) Exempt