The following data is part of a premarket notification filed by Meditech International, Inc. with the FDA for Ld-i 75 And Ld-i 200.
| Device ID | K072551 |
| 510k Number | K072551 |
| Device Name: | LD-I 75 AND LD-I 200 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-10 |
| Decision Date | 2008-04-02 |
| Summary: | summary |