The following data is part of a premarket notification filed by Hamilton Thorne, Inc. with the FDA for Hanilton Thorne Infrared Laser Optical System-zilos-tk Hamilton Thorne Infrared Laser Optical System-lykos.
| Device ID | K120055 |
| 510k Number | K120055 |
| Device Name: | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS |
| Classification | System, Assisted Reproduction Laser |
| Applicant | HAMILTON THORNE, INC. 100 CUMMINGS CENTER-SUITE 465E Beverly, MA 01915 |
| Contact | Diarmaid H Douglas-hamilton |
| Correspondent | Diarmaid H Douglas-hamilton HAMILTON THORNE, INC. 100 CUMMINGS CENTER-SUITE 465E Beverly, MA 01915 |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858604006290 | K120055 | 000 |