K133132 is an FDA 510(k) clearance for the OPTICAL BIOMETER AL-SCAN. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.
Submitted by Nidek Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on June 11, 2014 after a review of 254 days - an extended review cycle.
This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.
View all Nidek Co., Ltd. devices
NCT01729962
Completed
Observational
Industry-sponsored
Comparative Study of the Optical Biometer for Measurements of the Eye
Comparative Study of the Optical Biometer for the Measurements of Axial Length, Anterior Chamber Depth, Keratometry, Corneal Cylinder Axis, Corneal Thickness, White-to-White Distance, and Pupil Diameter
| Condition studied |
Normal Non-fluency; Cataract; Aphakic Eye; Eyes With Corneal Abnormality |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Karl G Stonecipher, M.D. |
| Sponsor |
Nidek Co. LTD.
(industry)
|
Started 2012-12-01
→
Primary completion 2013-04-01
→
Completed 2013-05-01
Primary outcome
Agreement and Precision Endpoints Analyses
Secondary outcome
Evaluation of Adverse Events Found During the Study
Study completed - no results published.
This trial concluded in 2013 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov