Clearance Summary
FLUOROPERM 151-OK, PARAGON HDS 100-OK received FDA 510(k) clearance under submission number K010109, sponsored by Paragon Vision Sciences. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-02-28.
- Submission: K010109
- Applicant / Sponsor: Paragon Vision Sciences
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2001-02-28
Classification & Regulation
This clearance is catalogued under FDA product code MUW and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.