EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
FDA 510(k) clearance K083560 · decided 2008-12-11
Clearance details
- K-number
- K083560
- Device name
- EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
- Applicant
- Lighthouse Technical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-02
- Decision date
- 2008-12-11
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Austin, TX, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.