Clearance Summary
SURGICAL HEADLIGHT received FDA 510(k) clearance under submission number K842515, sponsored by Good-Lite Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-08-02.
- Submission: K842515
- Applicant / Sponsor: Good-Lite Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1984-08-02
Classification & Regulation
This clearance is catalogued under FDA product code EBA and 21 CFR 872.4630, within the Dental review panel as a Class I device.