The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Mls-ac Derma Scanner.
| Device ID | K101430 |
| 510k Number | K101430 |
| Device Name: | MLS-AC DERMA SCANNER |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | ERCHONIA CORPORATION 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ERCHONIA CORPORATION 33 Golden Eagle Lane 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 | 2010-05-21 |
| Decision Date | 2010-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006193 | K101430 | 000 |