510(k) K120055
- Device
- HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
- Applicant
- HAMILTON THORNE, INC.
- 510(k) number
- K120055
- Product code
- MRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-24
- Date received
- 2012-01-09
- Regulation
- 884.6200
- Classification name
- System, Assisted Reproduction Laser
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIARMAID H DOUGLAS-HAMILTON
- Address
- 100 Cummings Center-Suite 465e Beverly MA US 01915 01915
FDA Registration Numbers#
- 3003843927
- 3009107689
- 3004871219
- 1221433
Source Documents#
Other 510(k) Records For Product Code MRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | 2021-07-02 |
| K192008 | LaserShot M, NaviLase | Vitrolife GmbH | 2020-03-25 |
| K141434 | SATURN 5 LASER | Research Instruments , Ltd. | 2015-02-18 |
| K083208 | SATURN ACTIVE LASER SYSTEM | Research Instruments , Ltd. | 2009-08-25 |
| K063636 | ZILOS-TK | Hamilton Thorne Biosciences | 2007-04-24 |
| K060764 | SATURN 3 LASER SYSTEM | Research Instruments , Ltd. | 2007-03-12 |
| K062524 | OCTAX LASER SHOT SYSTEM | Minitube of America, Inc. | 2006-12-15 |
| K050768 | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | Hamilton Thorne Biosciences | 2005-04-28 |
| DEN040009 | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) | Hamilton Thorne Biosciences | 2004-11-04 |
Legacy Summary#
summary
FDA Review#
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