K120055 is an FDA 510(k) clearance for the HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS. This device is classified as a System, Assisted Reproduction Laser (Class II - Special Controls, product code MRX).
Submitted by Hamilton Thorne, Inc. (Beverly, US). The FDA issued a Cleared decision on April 24, 2012, 106 days after receiving the submission on January 9, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6200. This System Is Inteded To Be Used To Drill A Small Tangential Hole In Or To Thin The Zona Pellucida Of The Embryo In Selected In Vitro Fertilization Patients With Otherwise Poor Prognois For Successful Pregnancy Outcome, Such As Advanced Maternal Age, Prior Failed In Vitro Fertilization Procedures, Cryopreserved Embryos, Or Abnormal Zona Pellucida Morphology..
| 510(k) Number | K120055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2012 |
| Decision Date | April 24, 2012 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MRX — System, Assisted Reproduction Laser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6200 |
| Definition | This System Is Inteded To Be Used To Drill A Small Tangential Hole In Or To Thin The Zona Pellucida Of The Embryo In Selected In Vitro Fertilization Patients With Otherwise Poor Prognois For Successful Pregnancy Outcome, Such As Advanced Maternal Age, Prior Failed In Vitro Fertilization Procedures, Cryopreserved Embryos, Or Abnormal Zona Pellucida Morphology. |