Clearance Summary
JEDMED/POLACK KERATOSCOPE HS/SL received FDA 510(k) clearance under submission number K882618, sponsored by Gamut Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-07-13.
- Submission: K882618
- Applicant / Sponsor: Gamut Ent.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1350
- Decision date: 1988-07-13
Classification & Regulation
This clearance is catalogued under FDA product code HLR and 21 CFR 886.1350, within the Ophthalmic review panel as a Class I device.