The following data is part of a premarket notification filed by International Medical Instruments, Inc. with the FDA for Lep2000 Therapy System.
| Device ID | K073689 |
| 510k Number | K073689 |
| Device Name: | LEP2000 THERAPY SYSTEM |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | INTERNATIONAL MEDICAL INSTRUMENTS, INC. 12101 CULLEN BLVD. SUITE A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich INTERNATIONAL MEDICAL INSTRUMENTS, INC. 12101 CULLEN BLVD. SUITE A Houston, TX 77047 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B420LEP2000PTS0 | K073689 | 000 |
| B420LEP2000100D0 | K073689 | 000 |
| B420LEP2000100C0 | K073689 | 000 |
| B420LEP2000100B0 | K073689 | 000 |
| B420LEP2000100A0 | K073689 | 000 |
| B420LD1000 | K073689 | 000 |