Indications for Use Statement 

510(k) Number: K082891 

Device Name: LENSTAR LS 900 

Indications for Use:
The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Refletometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determiniation of the appropriate power type of IOL (introcular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:

  • Axial eye length
  • Corneal thickness
  • Anterior chamber depth
  • Aqueous depth
  • Lens thickness
  • Radii of curvature of flat and steep meridian
  • Axis of the flat meridian
  • White to white distance
  • Pupil Diameter

 

Prescription Use (Part 21 CFR 801 Subpart D)