The following data is part of a premarket notification filed by Tuco Innovations, Inc. with the FDA for Erchonia Pl2000.
| Device ID | K012580 |
| 510k Number | K012580 |
| Device Name: | ERCHONIA PL2000 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | TUCO INNOVATIONS, INC. 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Wall |
| Correspondent | Kevin Wall TUCO INNOVATIONS, INC. 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2002-01-17 |