The following data is part of a premarket notification filed by Medx Electronics, Inc. with the FDA for Medx Lpt 200 Tethered Laser & Medx Lps 200 (oralase) Portable Laser.
| Device ID | K082707 |
| 510k Number | K082707 |
| Device Name: | MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDX ELECTRONICS, INC. 3350 RIDGEWAY DR. UNIT #3 Mississauga, Ontario, CA L5l 5z9 |
| Contact | Anita Saltmarche |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-16 |
| Decision Date | 2008-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628451918196 | K082707 | 000 |
| 00628451918240 | K082707 | 000 |