LightStim Professional LED Bed
FDA 510(k) clearance K153399 · decided 2016-07-05
Clearance details
- K-number
- K153399
- Device name
- LightStim Professional LED Bed
- Applicant
- Led Intellectual Properties, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-11-24
- Decision date
- 2016-07-05
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.