LED Light Therapy Device
FDA 510(k) clearance K180900 · decided 2018-07-10
Clearance details
- K-number
- K180900
- Device name
- LED Light Therapy Device
- Applicant
- Uvbiotek, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-04-06
- Decision date
- 2018-07-10
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- OLP
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.