Clearance Summary
Neutrogena Light Therapy Aging Mask+ received FDA 510(k) clearance under submission number K180856, sponsored by Johnson & Johnson Consumer, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-06-19.
- Submission: K180856
- Applicant / Sponsor: Johnson & Johnson Consumer, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2018-06-19
Classification & Regulation
This clearance is catalogued under FDA product code OHS and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.