K-LASER
Lamp, Infrared, Therapeutic Heating
ELTECH S.R.L
The following data is part of a premarket notification filed by Eltech S.r.l with the FDA for K-laser.
Pre-market Notification Details
| Device ID | K120604 |
| 510k Number | K120604 |
| Device Name: | K-LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ELTECH S.R.L 1185 W. MAIN ST Franklin, TN 37064 |
| Contact | Richard Albright |
| Correspondent | Richard Albright ELTECH S.R.L 1185 W. MAIN ST Franklin, TN 37064 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B317KCUBE40 | K120604 | 000 |
| B317KCUBE30 | K120604 | 000 |
| B317KCUBE20 | K120604 | 000 |
| B317KCUBE0 | K120604 | 000 |
Trademark Results [K-LASER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-LASER 77401769 3601204 Dead/Cancelled |
Albright, Richard J. 2008-02-20 |
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