The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature radii *Corneal cylinder axis *Anterior chamber depth *Central…
The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature radii *Corneal cylinder axis *Anterior chamber depth *Central corneal thickness *Crystalline lens thickness *White-to-white *Pupil diameter The Optical Biometer HBM-1 also measures corneal topography. The Optical Biometer HBM-1 also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Optical Biometer HBM-1 | Listed by | Huvitz Co., Ltd., South Korea |
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-18 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.