The following data is part of a premarket notification filed by Medx Electronics, Inc. with the FDA for Medx Lcs Laser Series.
| Device ID | K021985 |
| 510k Number | K021985 |
| Device Name: | MEDX LCS LASER SERIES |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | MEDX ELECTRONICS, INC. 3535 LAIRD ROAD UNIT 2 Mississauga, CA L5l 5y7 |
| Contact | Anita Saltmarche |
| Correspondent | Anita Saltmarche MEDX ELECTRONICS, INC. 3535 LAIRD ROAD UNIT 2 Mississauga, CA L5l 5y7 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2002-09-10 |
| Summary: | summary |