Clearance Summary
LASER SKIN MARKER AND MASK WHITE LOTION received FDA 510(k) clearance under submission number K861772, sponsored by Pacific Poly Crafts. 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 1986-05-21.
- Submission: K861772
- Applicant / Sponsor: Pacific Poly Crafts
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4660
- Decision date: 1986-05-21
Classification & Regulation
This clearance is catalogued under FDA product code FZZ and 21 CFR 878.4660, within the General, Plastic Surgery review panel as a Class I device.