The following data is part of a premarket notification filed by Riancorp Pty Ltd with the FDA for Ltu-904 Portable Laser Therapy Unit.
| Device ID | K030295 |
| 510k Number | K030295 |
| Device Name: | LTU-904 PORTABLE LASER THERAPY UNIT |
| Classification | Light, Lymphedema Reduction, Low Energy |
| Applicant | RIANCORP PTY LTD 5818 PRINCESS CAROLINE PLACE Leesburg, FL 34748 |
| Contact | Robert T Handren |
| Correspondent | Robert T Handren RIANCORP PTY LTD 5818 PRINCESS CAROLINE PLACE Leesburg, FL 34748 |
| Product Code | NZY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-28 |
| Decision Date | 2004-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09352877000135 | K030295 | 000 |