510(k) K030295
- Device
- LTU-904 PORTABLE LASER THERAPY UNIT
- Applicant
- RIANCORP PTY LTD
- 510(k) number
- K030295
- Product code
- NZY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-23
- Date received
- 2003-01-28
- Regulation
- 890.5500
- Classification name
- Light, Lymphedema Reduction, Low Energy
- Medical specialty
- Physical Medicine
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT T HANDREN
- Address
- 5818 Princess Caroline Pl. Leesburg FL US 34748 34748
FDA Registration Numbers#
- 3006738449
- 3007114368
Source Documents#
Legacy Summary#
summary
FDA Review#
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