510(k) K052674
K052674 is an FDA 510(k) premarket notification submitted by Meditron, GmbH for the device "CONTACT LENS OPHTHALMODYNAMOMETER". The FDA issued a decision of Substantially Equivalent on May 24, 2006. The device falls under product code NYK (Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)), a Class II device regulated under 21 CFR 886.1385. Meditron, GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2006
- Date Received
- September 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
- Device Class
- Class II
- Regulation Number
- 886.1385
- Review Panel
- OP
- Submission Type
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.