510(k) K030295
K030295 is an FDA 510(k) premarket notification submitted by Riancorp Pty, Ltd. for the device "LTU-904 PORTABLE LASER THERAPY UNIT". The FDA issued a decision of Substantially Equivalent on December 23, 2004. The device falls under product code NZY (Light, Lymphedema Reduction, Low Energy), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2004
- Date Received
- January 28, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Lymphedema Reduction, Low Energy
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.