Clearance Summary
M-PACT CORNEAL LIGHT SHIELD received FDA 510(k) clearance under submission number K993883, sponsored by M-Pact Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-12-21.
- Submission: K993883
- Applicant / Sponsor: M-Pact Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1999-12-21
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.