ZILOS-tk™
Catalogue number ZILOS-tk, listed by Hamilton Thorne, Inc., United States, under System, Assisted Reproduction Laser. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
Record
| Listed by | Hamilton Thorne, Inc., United States |
|---|---|
| FDA product code | MRX |
| Device type | System, Assisted Reproduction Laser |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K063636 |
| Record published | 2019-11-30 |
| Record revised | 2023-04-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZILOS-tk | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saturn 5 Laser System | Research Instruments Ltd | 34 |
| Octax LaserShot M | Octax Microscience GmbH | 1 |
| Lykos™ | Hamilton Thorne, Inc. | 1 |
| Lykos DTS | Hamilton Thorne, Inc. | 1 |
| Octax Laser Shot | Octax Microscience GmbH | 1 |
| Octax NaviLase | Octax Microscience GmbH | 1 |
| RI Saturn | Research Instruments Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202241 | 2021-07-02 |
| K120055 | 2012-04-24 |
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.