Clearance Summary
HEINE LAMBDA 100 received FDA 510(k) clearance under submission number K944156, sponsored by Heine USA , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-01-12.
- Submission: K944156
- Applicant / Sponsor: Heine USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 1995-01-12
Classification & Regulation
This clearance is catalogued under FDA product code HOX and 21 CFR 886.1150, within the Ophthalmic review panel as a Class I device.