Identity
- Trade Name
- LYKOS DTS FDA UDI
- Generic Name
- Assisted reproduction laser system FDA UDI
- Device Name
- This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening. FDA UDI
- Model / Reference
- LYKOS DTS FDA UDI
- Description
- This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858604006054 FDA UDI
- 510(k) Number
- K202241 FDA UDI
- FDA Product Code
- MRX FDA UDI
- GMDN Term
- Assisted reproduction laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction laser system
Lykos Dts by HAMILTON THORNE, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- HAMILTON THORNE, Inc.
Sources (1)
- FDA UDI 116d6782-63ce-4b23-aac0-5d470a39945c 34 fields · synced May 30, 2026