LTU-904 PORTABLE LASER THERAPY UNIT
FDA 510(k) clearance K030295 · decided 2004-12-23
Clearance details
- K-number
- K030295
- Device name
- LTU-904 PORTABLE LASER THERAPY UNIT
- Applicant
- Riancorp Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-28
- Decision date
- 2004-12-23
- Days to decision
- 695 days
- Clearance type
- Traditional
- Product code
- NZY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Leesburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.