Clearance Summary
LENSOMETER MODEL 11 received FDA 510(k) clearance under submission number K781440, sponsored by Rodenstock Instrument 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 1978-09-07.
- Submission: K781440
- Applicant / Sponsor: Rodenstock Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1425
- Decision date: 1978-09-07
Classification & Regulation
This clearance is catalogued under FDA product code HLM and 21 CFR 886.1425, within the Ophthalmic review panel as a Class I device.