Heine Omega 180
Heine - Omega 500 Unplugged With HC50 L Headband
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | HJI |
| Device type | Lens, Fundus, Hruby, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1395 |
| Establishment | Repacker / relabeller |
| 510(k) | K123316 |
| Record published | 2018-08-15 |
| Record revised | 2024-04-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-01-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C-004.33.503 | Withdrawn | |
| C-004.33.226 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PDT Laser (Vpdt) | Volk Optical Inc. | 1 |
| Alcon Grieshaber | Alcon Laboratories, Inc. | 1 |
| TransEquator (VTE) | Volk Optical Inc. | 1 |
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.