LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)— 510(k) K202241
Substantially EquivalentHamilton Thorne, Inc.
FDA 510(k) clearance K202241 for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS), Substantially Equivalent on 2021-07-02. Applicant: Hamilton Thorne, Inc.. Device class: 2.
Clearance details
- Applicant
- Hamilton Thorne, Inc.
- Product code
- Code MRX
- Device class
- Class 2
- Regulation
- 21 CFR 884.6200
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
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