Clearance Summary
SKIN-LITE received FDA 510(k) clearance under submission number K843300, sponsored by Guardian Chemical. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1984-11-07.
- Submission: K843300
- Applicant / Sponsor: Guardian Chemical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1984-11-07
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.