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 |