Lykos™
The listed LYKOS is named in the FDA filing as an infrared laser optical system configuration integrated within a microscope objective. The filing describes it for procedures involving an…
The listed LYKOS is named in the FDA filing as an infrared laser optical system configuration integrated within a microscope objective. The filing describes it for procedures involving an embryo’s zona pellucida.
Its stated use includes drilling a small tangential hole in or thinning the zona pellucida in selected IVF patients, and use in IVF patients undergoing preimplantation genetic diagnosis.
Configuration and Operation
The filing says the laser uses an infrared beam to locally heat a small spot on the zona pellucida. It describes the LYKOS configuration as mounting on the turret of an inverted microscope.
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) | K120055 |
| 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 |
|---|---|---|
| LYKOS | 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 DTS | Hamilton Thorne, Inc. | 1 |
| Octax Laser Shot | Octax Microscience GmbH | 1 |
| ZILOS-tk™ | Hamilton Thorne, Inc. | 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.