• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device tomography, optical coherence
Regulation Description Ophthalmoscope.
Definition Viewing, imaging, measurement, and analysis of ocular structures.Diagnostic device to aid in the detection and management of various ocular diseases.
Physical State Computerized imaging device consisting of light sources and beam delivery and scanning optics.
Technical Method Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.
Target Area Eye.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeOBO
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.1570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-