Clearance Summary
MAKROLON 2405 GOGGLES (LIGHT AND DARK) received FDA 510(k) clearance under submission number K945346, sponsored by Universal Massage & Tanning, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-11-22.
- Submission: K945346
- Applicant / Sponsor: Universal Massage & Tanning, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1994-11-22
Classification & Regulation
This clearance is catalogued under FDA product code HOY and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.