# K160327: Aladdin HW3.0

- Pathway: 510(k) (Traditional)
- Applicant: Visia Imaging S.R.L.
- Decided: Oct 5, 2016 after 243 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ALADDIN HW3.0 is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (CCT), lens thickness (LT), white-to-white (WTW) and pupil diameter of the human eye. ALADDIN HW3.0 also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN HW3.0 also aids in the calculation of the appropriate IOL power and type to be implanted. ALADDIN HW3.0 is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.

Source page: https://510kreport.com/device/K160327
Methodology: https://510kreport.com/methodology