The following data is part of a premarket notification filed by Eltech, S.r.l. with the FDA for K-laser K-1200, Model 12 W.
| Device ID | K091497 |
| 510k Number | K091497 |
| Device Name: | K-LASER K-1200, MODEL 12 W |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ELTECH, S.R.L. 311 S. ROYAL OAKS BLVD. SUITE 140-A Franklin, TN 37064 |
| Contact | Richard Albright |
| Correspondent | Richard Albright ELTECH, S.R.L. 311 S. ROYAL OAKS BLVD. SUITE 140-A 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 | 2009-05-20 |
| Decision Date | 2009-08-19 |
| Summary: | summary |