The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Lapex 2000.
| Device ID | K034009 |
| 510k Number | K034009 |
| Device Name: | LAPEX 2000 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | MERIDIAN CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MERIDIAN CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2005-01-21 |
| Summary: | summary |