LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
FDA 510(k) clearance K221775 · decided 2022-12-20
Clearance details
- K-number
- K221775
- Device name
- LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
- Applicant
- Light Tree Ventures Europe B.V.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-21
- Decision date
- 2022-12-20
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Den Haag, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.