The following data is part of a premarket notification filed by Medx Electronics, Inc. with the FDA for Medx1100 Console & Medx 100t And Duolight Laser Accessories, Medx 100 Portable Laser.
| Device ID | K032231 |
| 510k Number | K032231 |
| Device Name: | MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| 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 | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628451918387 | K032231 | 000 |
| 00628451918356 | K032231 | 000 |
| 00628451918301 | K032231 | 000 |
| 00628451918295 | K032231 | 000 |
| 00628451918226 | K032231 | 000 |
| 00628451918103 | K032231 | 000 |