The following data is part of a premarket notification filed by Elite Electromedical with the FDA for Elite Electromed L.i.t.e. 4/1.
| Device ID | K053507 |
| 510k Number | K053507 |
| Device Name: | ELITE ELECTROMED L.I.T.E. 4/1 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | ELITE ELECTROMEDICAL 4960 WILSON DR. Osage Beach, MO 65065 |
| Contact | Gary Huddleston |
| Correspondent | Gary Huddleston ELITE ELECTROMEDICAL 4960 WILSON DR. Osage Beach, MO 65065 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-03-15 |